Methods The psycho-educational intervention designed to improve self-management for symptom clusters among cancer patients was developed based on the results of a systematic review and
Trang 1Queensland University of Technology
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Supervisors
Principal Supervisor
Professor Patsy Yates
Head, School of Nursing,
Queensland University of Technology
Director, Centre for Palliative Care Research and Education, Queensland Health
Associate Supervisor
Associate Professor Kimberly Alexander
Senior Lecturer, School of Nursing,
Queensland University of Technology
Senior Research Fellow for Holy Spirit Northside Private Hospital
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Publications Related to this Thesis
Peer- reviewed publications
1 Nguyen LT, Yates P, Annoussamy LC, & Truong TQ The effectiveness of pharmacological interventions in the management of symptom clusters in adult cancer patients: A systematic review protocol JBI Database of Systematic Reviews and Implementation Reports 2016; 14(4): 49-59
non-Conference presentations
1 Nguyen LT, Yates P & Annoussamy LC How effective non-pharmacological interventions are in the management of symptom clusters among cancer patients?: A systematic review World Cancer Congress 2016, Paris, France
2 Nguyen LT, Yates P & Alexander K Development of an evidenced-based educational intervention to manage symptom clusters in cancer patients within the context of low-middle income country International Conference on Cancer Nursing
psycho-2017, Anaheim, California, United States
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Abstract
Rationale
Pain, fatigue and sleep disturbance form a common symptom cluster amongst cancer patients, regardless of host factors, cancer types or treatments Patients with this symptom cluster can experience high symptom burden with negative and synergistic impacts on their emotional well-being, performance status and health-related quality of life Most interventions to date have incorporated a single strategy and have focused on controlling one particular cancer symptom Our recent systematic review has identified that significant improvements in the control of multiple concurrent symptoms are more likely to occur when multicomponent interventions are employed Given the dynamic and complex nature of symptom clusters experienced by cancer patients, a psycho-educational intervention incorporating an education program, coaching in relation to symptom self-management behaviours, and emotional support, have significant potential
Aims
This study focused on undertaking a preliminary evaluation of a psycho-educational intervention to improve management of a cancer-related symptom cluster comprising pain, fatigue and sleep disturbance and reduce symptom cluster impacts on patient health outcomes
Methods
The psycho-educational intervention designed to improve self-management for symptom clusters among cancer patients was developed based on the results of a systematic review and informed by elements of the Revised Symptom Management Conceptual Model and the Individual and Family Self-Management theory The applicability of the proposed
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intervention within the Vietnamese context was facilitated by consulting with 10 cancer patients through semi-structured interviews (Study 1) In Study 2, a parallel group single blind pilot quasi-experimental trial was conducted to undertake a preliminary assessment of the feasibility, efficacy and acceptability of the intervention in reducing the symptom cluster burden and the impacts of symptom clusters on cancer patients’ health outcomes Patient inclusion criteria were: (1) adults with any type of cancer, (2) expected prognosis of at least
12 months, (3) had finished the second chemotherapy cycle, (4) Karnofsky level of ≥ 60/100, (5) reported three symptoms: fatigue, pain and sleep disturbance at severity level of equal or above 3 during the past 7 days Exclusion criteria were: (1) diagnosed with psychiatric morbidity; (2) inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment The intervention group received an individualised psycho-educational intervention consisting of one face-to-face session and two booster phone sessions one week apart Outcome measures included Symptom Numeric Rating Scales, the Brief Fatigue Inventory, the Brief Pain Inventory, the Pittsburg Sleep Quality Index, the Hospital Anxiety and Depression Scale, the Karnofsky Performance Scale, and the EuroQol-5D-5L Patient outcomes were measured at baseline (T1: pre-intervention) prior to the chemotherapy cycle and one follow-up time point immediately preceding the next chemotherapy cycle (T2: post-intervention)
Results
The study is highly practical, with only five months required to recruit 102 cancer patients (recruitment rate of 22.6% and attrition rate of 9.8%) Compared to the control group, the psycho-educational intervention group showed a significant reduction in symptom cluster severity, fatigue burden, sleep disturbance, and depressive symptoms The differences were not observed between groups by time interaction for pain, functional status and health-related
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quality of life The intervention was valued and acceptable to the study population, with a high attendance rate of 78% and adherence rate of 95.7%
Conclusions
This study represents one of the few symptom cluster intervention studies to examine a psycho-educational program focusing on the most common cancer-related symptom cluster Findings indicate the intervention is feasible, acceptable and has potential benefits in terms of relieving the target symptoms at cluster and individual levels These findings from this study will inform the development of a full scale trial to test the effectiveness of a psycho-educational intervention in management of this symptom cluster
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Table of Contents
Supervisors i
Publications Related to this Thesis ii
Keywords iii
Abstract iv
Table of Contents vii
List of Figures xvii
List of Tables xviii
List of Abbreviations xx
Definitions of Terms xxi
Statement of Original Authorship xxiii
Acknowledgement xxiv
Chapter 1 Introduction 1
Background to the Study 1
1.1.1 Scope of the problem 1
1.1.2 Principles underpinning symptom management intervention in this study 3
Statement of the Problem 5
Purposes and Specific Aims of the Study 6
Research Questions 6
Research Plan 6
Significances of the Study 7
Thesis Outline 7
Chapter 2 Cancer-related Symptom Clusters 9
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Introduction 9
Prevalence of Multiple Symptoms 9
Definitions of Symptom Clusters 10
Cancer-related Symptom Cluster Identification 12
2.4.1 All-possible symptom approach 13
2.4.1.1 Statistical analysis used to identify symptom clusters 13
2.4.1.2 Clusters of symptoms identified 14
2.4.2 Most-common symptom approach 17
2.4.2.1 Statistical analysis used to identify symptom clusters 17
2.4.2.2 Clusters of symptoms identified 17
Impacts of Symptom Clusters on Patient Outcomes 19
2.5.1 Impacts of individual symptoms on patients 19
2.5.2 Impacts of symptom synergism on patients 20
2.5.2.1 Subgroups of symptom approach 21
2.5.2.2 Subgroups of patient approach 22
The Symptom Cluster of Fatigue, Pain and Sleep Disturbance 23
2.6.1 Interrelationships between selected symptoms within cluster 25
2.6.2 Mechanisms underpinning the selected symptom cluster 26
Chapter Summary 28
Chapter 3 Non-Pharmacological Interventions Managing Symptom 29
Introduction 29
Objectives and Methodology 29
3.2.1 Objectives 29
3.2.2 Inclusion criteria 29
3.2.2.1 Types of participants 29
3.2.2.2 Types of interventions 30
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3.2.2.3 Outcomes 31
3.2.2.4 Types of studies 31
3.2.3 Search strategy 31
3.2.4 Assessment of methodological quality 33
3.2.5 Data extraction 34
3.2.6 Data synthesis 34
Results 34
3.3.1 Description of studies 34
3.3.1.1 Excluded and ongoing studies 35
3.3.1.2 Included studies 36
3.3.2 The concept of symptom clusters 38
3.3.3 Symptom clusters identified 39
3.3.4 Symptom clusters targeted 40
3.3.5 Clinical contexts 40
3.3.5.1 Demographic characteristics 40
3.3.5.2 Disease characteristics 41
3.3.5.3 Cancer treatments 42
3.3.5.4 Other criteria for inclusion 42
3.3.6 Other study characteristics 43
3.3.7 Outcome measurements 44
3.3.8 Methodological quality 45
3.3.9 Risk of bias in included studies 46
3.3.10 Interventions 46
3.3.10.1 Models of delivering 46
3.3.10.2 Dosages of interventions 47
3.3.10.3 Other intervention characteristics 48
3.3.10.4 Effects according to intervention types 48
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3.3.10.5 Comparison of effective and non-effective interventions 59
Discussion 62
3.4.1 Strengths and weaknesses of the review 62
3.4.2 Implications for practice 63
3.4.3 Implications for research 64
Chapter Conclusions 64
Chapter 4 Theoretical Framework 66
Chapter Introduction 66
Self-Management in Chronic Illness 66
Concepts of Self-Management and Symptom Self-Management 68
Theory of Symptom Self-Management 70
Theoretical Framework: the Revised Symptom Management Conceptual Model 71 4.5.1 Symptom experience 74
4.5.2 Symptom management strategies 75
4.5.3 Symptom outcomes 76
4.5.4 Summary 76
Theoretical Framework: The Individual and Family Self-Management Theory 78
4.6.1 Process of self-management 83
4.6.1.1 Knowledge and beliefs 83
4.6.1.2 Self-regulation skills and abilities 84
4.6.1.3 Social facilitation 85
4.6.2 Outcomes 87
4.6.3 Summary 88
The Synthesis of the Revised Symptom Management Conceptual Model with the Individual and Family Self-management Theory 89
4.7.1 Contextual factors 89
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4.7.1.1 Health and illness conditions 90
4.7.1.2 Environment factors 92
4.7.1.3 Individual and family factors 95
4.7.2 Self-management support intervention 100
4.7.2.1 Educational sessions 100
4.7.2.2 Symptom self-management action plans 102
4.7.2.3 Emotional and social support 105
Preliminary Conceptual Framework for the Study 107
Chapter Summary 108
Chapter 5 Methods 110
Chapter Introduction 110
Overall Research Design 110
5.2.1 Study 1: Developing intervention, translating and validating the instrument 111
5.2.2 Study 2: Pilot testing the intervention 111
Phase 1 of Study 1: Semi-structured Interviews 113
5.3.1 Aims 113
5.3.2 Setting 113
5.3.3 Design 113
5.3.3.1 Sampling frame 114
5.3.3.2 Recruitment procedure 115
5.3.3.3 Interviews 116
5.3.3.4 Screening instruments 118
5.3.3.5 Quantitative analysis 118
5.3.3.6 Qualitative content analysis 119
Phase 2 of Study 1: Translation and Validation 122
5.4.1 Translation process 122
5.4.2 Content validity 123
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Study 2 124
5.5.1 Aims 124
5.5.2 Research questions 124
5.5.3 Setting 126
5.5.4 Design 126
5.5.4.1 Sample size 126
5.5.4.2 Sampling frame 126
5.5.4.3 Recruitment procedure 128
5.5.4.4 Contamination 128
5.5.4.5 Allocation 129
5.5.4.6 Standard care 129
5.5.4.7 Psycho-educational intervention 130
5.5.4.8 Expertise aspects 137
5.5.4.9 Timing of measurements 137
5.5.4.10 Instruments 138
5.5.4.11 Data analysis 147
5.5.4.12 Clinical significance 150
5.5.4.13 Strategies to reduce attrition 150
5.5.4.14 Missing data management 151
5.5.4.15 Ethical considerations 151
Chapter Summary 154
Chapter 6 Intervention Adaptation and Instrument Validation 155
Chapter Introduction 155
Semi-structured Interviews 155
6.2.1 Sample characteristics 155
6.2.2 Findings from semi-structured interviews 157
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6.2.3 Perceived applicability/relevance 158
6.2.3.1 Complexity of condition 158
6.2.3.2 Information needs 159
6.2.4 Perceived usefulness 160
6.2.4.1 Gaining symptom self-care knowledge 160
6.2.4.2 Self-regulation skills 160
6.2.4.3 Social facilitation 161
6.2.4.4 Improved health outcomes 161
6.2.5 Perceived acceptability 162
6.2.5.1 Proposed information 162
6.2.5.2 Preference for intervention components 163
6.2.6 Perceived feasibility 164
6.2.6.1 Perceived barriers 164
6.2.6.2 Family involvement 165
6.2.6.3 Participant recommendations 166
6.2.7 Symptom self-management behaviours 168
6.2.7.1 Sleep hygiene 168
6.2.7.2 Nutrition 168
6.2.7.3 Medication 169
6.2.7.4 Activity 169
6.2.7.5 Cognitive 170
6.2.7.6 Complementary therapy 170
6.2.8 Conclusions 170
Translation and Validation Process 171
6.3.1 Forward translation 171
6.3.2 Backward translation 172
6.3.3 Comparison between backward translation version and original instrument 172
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6.3.4 Expert panel reviews of the instrument 175
Chapter Summary 177
Chapter 7 Results of the Quasi-Experimental Trial 178
Chapter Introduction 178
Missing Data Management 178
7.2.1 Objectives 1 and objective 3: Feasibility and acceptability 178
7.2.2 Objective 2: Preliminary effectiveness 179
Research Objective 1: Feasibility 179
7.3.1 Recruitment process 182
7.3.2 Characteristics of included and excluded participants 183
7.3.3 Baseline characteristics of the intervention and control groups 184
7.3.4 Instrument reliability 188
7.3.5 Data completeness 188
7.3.6 Characteristics of patients who withdrew 189
7.3.7 Baseline measures for patients who subsequently withdrew 191
Research Objective 2: Preliminary Effectiveness of the Intervention 193
7.4.1 Outcome measurements at baseline 193
7.4.2 The correlations among symptoms within a cluster 194
7.4.3 Effects of the intervention 196
7.4.3.1 Effects of the intervention on primary outcomes 196
7.4.3.2 Effects of the intervention on secondary outcomes 200
7.4.3.3 Clinical significance 202
Research Objective 3: Acceptability 203
7.5.1 Burden of research measurements 203
7.5.2 Family involvement 204
7.5.3 Patients’ attendance adherence 205
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7.5.4 Symptom self-management adherence 206
7.5.5 Factors associated with intervention adherences 207
7.5.6 Patients’ perception of the acceptability of the intervention 211
Chapter Summary 214
Chapter 8 Discussion and Conclusions 216
Chapter Introduction 216
Feasibility of the Study 216
Effectiveness of the Intervention 221
8.3.1 Symptom cluster severity 221
8.3.2 Individual symptoms 223
8.3.3 Secondary outcomes 228
Acceptability of the Intervention 231
8.4.1 Response burden 231
8.4.2 Family involvement 232
8.4.3 Intervention attendance and adherence 233
8.4.4 Overall patients’ acceptance 235
Implications 236
8.5.1 Theoretical implications 236
8.5.2 Clinical implications 239
8.5.3 Health policy implications 241
8.5.4 Nursing education implications 244
Future Studies 245
Limitations 249
Conclusions 251
Bibliography 253
Appendices 301
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Appendix 1: Studies identifying clusters in cancer patients by all-possible symptom approach301 Appendix 2: Studies identifying clusters in cancer patients by most-common symptom approach
306
Appendix 3: Appraisal instrument 308
Appendix 4: Data extraction instrument 309
Appendix 5: Characteristics of excluded studies (ordered by study ID) 311
Appendix 6: Characteristics of ongoing studies (ordered by study ID) 313
Appendix 7: Characteristics of included studies (ordered by study ID) 314
Appendix 8: Methodological quality of included studies (ordered by study ID) 320
Appendix 9: Characteristics of interventions (ordered by Study ID) 321
Appendix 10: Permission granted by John Wiley and Sons to reprint the Revised Symptom Management Conceptual Model 333
Appendix 11: Permission granted by Elsevier to reprint the Individual and Family Self-Management Theory 334
Appendix 12: Permission to reuse the Individual and Family Self-Management Theory 335
Appendix 13: Permissions to use the materials published 336
Appendix 14: Table of contents – “Coping with Cancer” booklet 337
Appendix 15: Authorisation to use available instruments 338
Appendix 16: Ethics approvals 343
Appendix 17: Sensitivity analysis 356
Appendix 18: Histograms and normal Q-E plots of variables 357
Appendix 19: The significant associations between outcome variables and baseline characteristics 364 Appendix 20: The associations between outcome measurements at baseline 365
Appendix 21: Instruments 366
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List of Figures
Figure 3.1 Flow diagram of study inclusion process 37
Figure 4.1 The Revised Symptom Management Conceptual Model 73
Figure 4.2 The Individual and Family Self-Management Theory 82
Figure 4.3 Preliminary conceptual framework of this study 108
Figure 5.1 Overall research design for the study 112
Figure 5.2 Translation process 123
Figure 5.3 The flowchart of participants through the study 136
Figure 5.4 Time points for pre- and post-intervention assessments by treatment group 138
Figure 7.1 Study flow chart 181
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List of Tables
Table 5.1 Question list used in the interviews 117
Table 5.2 Var iables, measur es, and data collection over view 146
Table 6.1 Semi-structured interviews: sample characteristics 156
Table 6.2 Categorisation matrix 157
Table 6.3 Comparisons between versions during translation process 173
Table 6.4 Amendment report outlining modifications and the rationales for the modifications 176
Table 7.1 Ineligibility and non-participation rates 183
Table 7.2 Demographic and clinical characteristics of excluded and included participants 184
Table 7.3 Sociodemographic by groups 186
Table 7.4 Clinical characteristics by groups 187
Table 7.5 Instrument reliability 188
Table 7.6 Reasons for attrition 189
Table 7.7 Characteristics by patients who stayed and withdrew 190
Table 7.8 Baseline outcome variable scores for patients who completed and who withdrew 192
Table 7.9 Intercorrelations among symptoms within a cluster 194
Table 7.10 Outcome variables by groups at baseline 195
Table 7.11 Pairwise comparison of symptom cluster by group and time interaction (Group x Time) 197
Table 7.12 Pairwise comparison of symptom cluster within groups (Time) and between groups (Group) (Post-hoc test adjustment) 197
Table 7.13 Pairwise comparisons of individual symptoms by group and time interaction (Group x Time) 198
Table 7.14 Pairwise comparisons of individual symptoms within groups (Time) and between groups (Group) (Post-hoc test adjustment) 199
Table 7.15 Pairwise comparisons of secondary outcome variables by group and time interaction (Group x Time) 201
Table 7.16 Pairwise comparisons of distal outcome variables within groups (Time) and between groups (Group) (Post-hoc test adjustment) 202 Table 7.17 Minimal clinically significant differences of primary outcome variables203
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Table 7.18 Length of time to fill out questionnaires 204
Table 7.19 Family involvement 204
Table 7.20 Intervention attendance rate 205
Table 7.21 Duration of the intervention sessions 206
Table 7.22 Symptom self-management strategies 207
Table 7.23 Background characteristics associated with intervention attendance 209
Table 7.24 Background characteristics associated with the frequency of use of the symptom self-management diary 211
Table 7.25 Total intervention acceptability score 213
Table 7.26 Descriptive results of the intervention acceptability 214
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List of Abbreviations
ASCPRO Assessing the Symptoms of Cancer Using Patient-Reported Outcomes
EQ-5D-5L Five dimensions of health-related quality of life
EQ VAS Overall health-related quality of life
HADS-D Hospital Anxiety and Depression Scale- Depressive Symptoms
MASTARI Meta-Analysis of Statistics Assessment and Review Instrument
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Definitions of Terms
Cancer A large range of diseases, in which some of the body's cells
become defective, begin to multiply out of control, can invade and damage the area around them, and can also spread to other parts of the body to cause further damage.1
Functional status The terms functional status and performance status are used
interchangeably throughout this dissertation Functional status is
an individual's ability to perform normal daily activities required
to meet basic needs, fulfil usual roles, and maintain health and well-being.2
Health-related
quality of life
Health-related quality of life (HRQOL) is an individual's or a group's perceived physical health, role functioning, social, and psychological aspects of well-being and functioning.3
Psycho-educational
intervention
Psycho-educational interventions encompass a broad range of activities that combine education and other activities such as counselling and supportive interventions.4
Self-efficacy Self-efficacy refers to people’s judgment about their capabilities
to organise and execute a course of action which requires designated types of performance.5
Self-management Self-management integrates the skills and choices of individuals,
with the services and support they receive from (1) the social environment of family, friends, worksites, organizations, and cultures; and (2) the physical and policy environments of neighbourhoods, communities, and governments, to monitor and manage his/her health condition and/or its impact.6
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Symptom A symptom is any subjective evidence of a disease, health
condition, or treatment-related effect that can be noticed and known only by the patient.8
Symptom cluster A symptom cluster refers to at least three symptoms that need to
be both related to one another and occurring concurrently9
Symptom
self-management
The terms symptom self-management and self-management of symptoms are used interchangeably throughout this dissertation Symptom self-management is defined as a dynamic, self-directed process involving patients’ ability along with accessible support they receive to improve the management of symptoms.11
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Statement of Original Authorship
The work contained in this thesis has not been previously submitted to meet requirement for
an award at this or any other education institution To the best of my knowledge and belief, the thesis contains no material previously published or written by another person
except where due reference is made
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Acknowledgement
It would not have been possible to write this doctoral thesis without the help and support of the kind people around me, only some of whom it is possible to give particular mention to here
I wish to thank, first and foremost, my principal supervisor Professor Patsy Yates Her mentorship and spirit of excellence have provided a solid foundation for my long-term career
in healthcare research I am proud to be one of her students and honoured to have worked with her during my PhD journey Without her guidance and support, this thesis would not have been possible
It is with immense gratitude that I acknowledge the support of my associate supervisor
Dr Kimberly Alexander Appreciation is extended to Professor Christine Miaskowski and Professor Janet Hardy for their advice related to the study methods
Over the duration of this doctoral study, I received scholarships given by the Vietnamese Nursing Project (the Atlantic Philanthropies) and the Queensland University of Technology I would like to express my heartfelt appreciation to these sponsors
My expert panel, translators and research assistants, H.T M Huyen, C.V Tuyen, L.N.T Tuyen, L Hien, N.T Huong, H.L Van, D.T Ha, D.V Tuyen, N.M Ngoc, P.T Hanh, N.T Trang and D.K Ly, many thanks to them for their fantastic collaborative work I also thank my friends for their support and understanding during this time
Professional editor, Dr Christina Houen of Perfect Words Editing provided copyediting and proofreading services according to the guidelines laid out in the university-endorsed guidelines and the Australian Standards for editing research theses
This thesis is dedicated to my parents (Dang Thi Hoa and Nguyen Van Vinh) who have
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supported me throughout my life and who dealt with my absence, including looking after my son, with smiles My sister (Nguyen Phuong Thuy), my brother (Tran Anh Tuan) and their kids (Tuan Nghia, Phuong Thao and Luna) have given me their unequivocal support and love, as always, for which my mere expression of thanks likewise does not suffice I would not have been able to overcome the challenges during the last three years without my family
I am most grateful to Dr Lourdes Annousammy who can see the best of me and encourage me to push my limits and to grow personally and professionally If I can become who I am today, it is thanks to him who has always supported me throughout with companionship, excellence, encouragement and guidance He is truly my inspiration and my family This thesis is dedicated to him
Last, but no means least, to my favourite man in the world, my son Tran Nguyen Tri Bach He has taught me not only how to be a mother but also above all, to be a better person
I am so proud to be his mother and to him, I attribute my love for life and learning Mẹ yêu
con rất nhiều, con trai của mẹ (I love you so much, my son)
My very best,
Nguyen Thuy Ly (NTL)
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Chapter 1 Introduction
Background to the Study
1.1.1.Scope of the problem
Cancer is a major concern in all countries around the world Recent statistics indicate that in 2012, there were 14.1 million new cases of cancer and 32.6 million persons alive with cancer within five years from time of diagnosis.12 Globally, the most common cancer and cause of cancer-related mortality is lung cancer in men (16.7%) and breast cancer in women (25.2%).13 Global cancer rates are predicted to increase by 50% within 18 years, from 10 million in 2002, to 15 million cases in 2020 Lack of cancer treatment facilities and life–extending therapies mean that outcomes from cancer and other chronic diseases in less developed countries are worse than those in developed countries.14 A total of 56% of the new cases of cancer and 64% of cancer deaths around the world occur in economically developing countries.13
In Vietnam, the national cancer incidence rate is estimated to be more than 125,000 new cancer cases annually,12 with only 5% of these people receiving prompt treatment.15 The incidence of cancer after 40 in both sexes, and the number of children diagnosed with cancer, have increased.16 The most common cancers for both genders in Vietnam are liver, lung, stomach, breast, and colorectal.12 The geographical distribution of cancer incidence is not identical across the country For example, the incidence of lung, stomach, nasopharynx and breast cancer is higher in the North than in the South.16 Despite the growing need for oncology care, cancer treatment facilities are inadequate in Vietnam, and a National Cancer Control Program is still in development.17 The Ministry of Health has instituted several initiatives to prevent cancer, including a national tobacco control program and Human Papilloma Virus (HPV) vaccinations; however, coverage of these programs is insufficient.17
At the same time, patients with cancer have limited access to care, and delayed diagnosis, due
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to lack of diagnostic facilities.18 The Vietnamese health care system is struggling to control the increasing number of cancer cases every year, as well as to manage cancer and its impact
on patients so as to reduce personal and health service burdens
The goal of caring for patients with cancer is not only to cure, but also to promote the highest possible quality of life.19 This requires preventing, addressing and relieving symptoms and side-effects that patients can experience due to their condition and treatment There has been limited research in Vietnam into patients’ experiences and supportive care services during cancer treatment Studies undertaken in Vietnam relating to palliative care services in oncology settings have also identified numerous difficulties and challenges, with only a small number of well-trained health professionals.15
From a nursing perspective, gaps in palliative care knowledge have been identified in Vietnam One study by Nguyen et al (2014)20 identified that oncology nurses had low scores
in palliative care knowledge related to symptom management, and psychological and spiritual aspects Other studies have identified that the majority of healthcare professionals report that they do not have adequate facilities to manage symptoms.15 This lack of knowledge and facilities to manage cancer-related symptoms during treatment and in palliative care means there is likely to be a high level of unmet need for symptom control among people with cancer Indeed, Green et al.’s (2006) study15 in a Vietnamese health care setting reported that approximately 90% of patients with cancer and Human Immunodeficiency Virus (HIV) experienced moderate to severe distress from symptoms The study also identified the negative impacts of symptoms on patients’ performance status and quality of life The limited research available means there is a significant gap in supportive care for cancer patients in Vietnam Studies to establish optimal symptom management strategies to reduce the impact of cancer-related symptoms and to foster patients’ quality of life are therefore needed
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1.1.2.Principles underpinning symptom management intervention in this study
Given the gap in evidence to support cancer symptom management in Vietnam, the overall aim of this study was to develop and test an evidence-based psycho-educational intervention to improve patients’ self-management of symptoms, in order to mitigate the impacts of cancer-related symptoms for patients undergoing treatment in Vietnam A number
of key principles informed the development of this intervention Firstly, in recent years, considerable attention has been given to understanding the complexity of cancer symptom management in order to advance symptom management science A key development in the field is the growing understanding that cancer symptoms seldom occur individually, but rather they commonly occur in clusters.21-30
The evidence which demonstrates the high prevalence of symptom clusters amongst cancer patients presents a number of challenges for researchers interested in conducting trials
of interventions in this field For example, the mechanisms that are both necessary and sufficient to induce the development of cancer symptom clusters are complex and insufficiently understood.31-36 The development of science in the field of symptom clusters is thus in its infancy, with research reflecting differing understandings of the characteristics of symptom clusters Moreover, there is inconsistency in methods and study samples used to investigate the problem The resulting lack of clarity about the aetiology and significance of symptom clusters means that effective interventions to manage symptoms as a cluster are not well developed Despite these limitations, the current study is based on the premise that advances in cancer symptom management require researchers to extend their focus beyond interventions for single symptoms, in order to address the fact that most patients experience clusters of symptoms
To provide a focus for the present study, a review of the literature was conducted to identify the most common symptom clusters experienced by patients (see Chapter 2) The
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available literature describes a wide range of cancer symptom clusters, depending on diagnosis, treatment, and stage of disease.37-40 Our review identified that fatigue, pain and sleep disturbance are the most commonly reported cluster,41-45 and as such will be the symptom cluster that is the focus of this research
Moreover, to determine an approach to managing symptom clusters, the complex multifactorial causes of the symptom cluster of interest were considered This complexity required that symptom management strategies incorporated multifaceted approaches which involved both pharmacological and non-pharmacological strategies.46-49 This approach was supported by the increasing number of studies which have tested the effectiveness of multicomponent pharmacological and non-pharmacological strategies in managing multiple symptoms in clusters.50-67 As such, from a nursing perspective, the primary focus of this research was identified as being evaluation of the use of non-pharmacological strategies as adjuncts to pharmacological strategies to manage cancer-related symptoms
Integral to many non-pharmacological approaches to symptom management is patient engagement and self-management That is, as cancer is now often considered a chronic condition,68-70 many symptoms and side-effects experienced in the short as well as the long term require patients to engage in a range of self-management behaviours to implement symptom management interventions.71,72 This is because healthcare models have shifted from inpatient to outpatient care delivery, requiring patients to take more responsibility for their own care The emphasis on outpatient care is reported not only in developed countries,73,74but also in developing nations,75 including Vietnam.76 As such, unlike inpatient settings where cancer patients are able to seek care from health professionals for symptom management on a regular basis, outpatient care requires patients to play a greater role in controlling cancer-related symptoms.77 Irrespective of multifaceted interventions that may be involved in a cancer symptom management plan,78-81 self-management is integral to its
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effectiveness Most symptom management interventions therefore require patients to engage
in a range of self-management behaviours to implement prescribed therapies, engage in healthy behaviours, and adapt to their cancer and its effects on their day to day life in the short and long term.71
Statement of the Problem
Previous research in Western contexts provides valuable insight into the benefits of self-management for cancer-related symptoms However, to date, limited research on symptom management has been conducted in Vietnam The growing body of literature on this topic in the Western world indicates that patient engagement in performing various self-management strategies is crucial to achieve a successful symptom management program.82-84Patients’ motivation for self-management greatly depends on a range of personal, health and illness, and sociocultural factors.8,85,86 However, inconsistent results across a number of studies in different contexts have highlighted that there is considerable variation in the nature, scope and approaches to supporting self-management behaviours.87,88
Findings from previous studies reflect some common, but also some distinct management behaviours among Asian patients when compared to those from Western countries, due to the difference in sociocultural contexts.89,90 Moreover, compared to other chronic conditions, such as diabetes and asthma, self-management research developed specifically for patients with cancer is limited.91 Effective evidence-based interventions have the potential to reduce the impact of multiple symptoms and improve health and wellbeing It
self-is hypothesself-ised that thself-is pilot study of a tailored psycho-educational intervention suitable for the Vietnamese sociocultural context can provide Vietnamese patients with the required knowledge and skills to achieve optimal symptom self-management, as well as to communicate better with health professionals so as to reduce their symptom levels
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Purposes and Specific Aims of the Study
The purposes of this pilot quasi-experimental trial were to (1) determine the feasibility
and acceptability of undertaking an experimental trial in Vietnam; and (2) undertake a preliminary assessment of the efficacy of a psycho-educational intervention in managing symptom clusters comprising pain, fatigue and sleep disturbance and reducing symptom cluster impacts on health outcomes amongst Vietnamese cancer patients
In order to achieve the purposes of the study, the specific aims for the study were to:
(1) Develop a psycho-educational intervention specifically designed to target symptom clusters comprising pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients undergoing treatment;
(2) Assess the feasibility and acceptability of the psycho-educational intervention to Vietnamese patients;
(3) Provide proof of principles for any positive contributions of the psycho-educational intervention via a pilot quasi-experimental trial with Vietnamese cancer patients
Research Questions
There were two main research questions:
(1) To what extent is the psycho-educational intervention feasible and acceptable to cancer patients undergoing treatment in Vietnam?
(2) Compared to usual care, to what extent is the psycho-educational intervention effective
in managing fatigue, pain and sleep disturbance at individual and cluster levels and in improving health outcomes among cancer patients undergoing treatment in Vietnam?
Research Plan
To achieve these objectives, a two-phase research design was used Study 1 focused on the development and modification of a psycho-educational symptom management intervention for cancer patients The development of the intervention was conducted through
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a systematic review and consultation with an expert panel The adaptation of the intervention
to ensure applicability to the Vietnamese context was then assessed by receiving feedback from patients in semi-structured interviews Informed by the results of Study 1, Study 2 involved a pilot quasi-experimental trial of the symptom management program for Vietnamese cancer patients undergoing treatment Preliminary evaluation of the effectiveness
of the intervention was undertaken through the comparison of the changes in severity of fatigue, pain, and sleep disturbance at individual and cluster levels for those who were and who were not exposed to the intervention The impacts of symptom clusters on psychological and performance status and health-related quality of life over time in both intervention and control groups were also evaluated
Significances of the Study
This study provides empirical evidence about the feasibility and acceptability of a tailored psycho-educational intervention for symptom cluster management that can be integrated into the everyday lives of Vietnamese cancer patients undergoing treatment It is hypothesised that by enhancing Vietnamese cancer patients’ ability to manage symptom clusters during cancer treatment, we can prevent or reduce multiple concurrent symptoms, increase patients’ adherence to treatments, and thereby improve quality of life in the short term
Thesis Outline
The thesis consists of six chapters Chapter One describes the background and scope
of the problem, the research questions and the design and methods of the proposed study
Chapter Two provides a review of literature on symptom clusters among patients with
cancer This chapter discusses the prevalence, definitions and identification of symptom clusters and impacts of symptom clusters on patient outcomes This is followed by discussion
of the most common symptom cluster reported in the literature: fatigue, pain and sleep
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disturbance, along with proposed mechanisms underpinning the cluster Chapter Three
presents the findings of a systematic review focused on assessing the effectiveness of a range
of non-pharmacological interventions for reducing symptom clusters in adult cancer patients
Chapter Four presents definitions of self-management and the roles of self-management in
chronic disease, particularly in cancer and symptom management A conceptual framework underpinning the design of the study, which involves the synthesis of the Individual and Family Self-Management Theory and the Revised Theory of Symptom Management
Conceptual Model, is also presented in Chapter Four Chapter Five presents a research plan consistent with the conceptual framework for the two studies of the project Chapter Six
present the findings of semi-structured interviews among cancer patients, to develop an evidence-based psycho-educational intervention which includes Vietnamese cultural and healthcare system considerations This chapter also describes the translation and validation
process of the instrument used in the study Chapter Seven presents the results of a pilot quasi-experimental trial to explore the study research questions Chapter Eight provides a
discussion of the major findings of this study, and considers the implications of the research for future research, nursing education and practice
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Chapter 2 Cancer-related Symptom Clusters
Introduction
People with cancer often report a diversity of symptoms as a consequence of their disease and its treatments, and a number of studies indicate that cancer patients undergoing active treatment report multiple symptoms simultaneously.92 This chapter starts with a review
of the literature on the prevalence of multiple symptoms experienced by cancer patients This
is followed by a discussion of the concept of symptom clusters and a review of the occurrence of symptom clusters across various cancers The impacts of symptom clusters on patient outcomes are also reviewed The chapter concludes with a discussion of the rationale for selecting a particular symptom cluster as the focus of the present study
Prevalence of Multiple Symptoms
Modern cancer treatment typically involves a variety of treatment approaches (e.g., chemotherapy, radiotherapy and surgery), either singly or in combination Despite the benefits of these treatment approaches in improving survival rates,93-95 cancer treatments are often associated with a variety of treatment-related side-effects and symptoms Depending on the patient sample as well as the methodology employed, and various measurements used, approximately 40% to 61% of cancer patients across diagnostic groups at different times of their disease trajectory experience at least two symptoms.96 Among those, 22% to 30% of patients report having more than five symptoms The significance of disease and treatment-related effects is increasingly recognised, and it is now recommended that a core set of common symptoms should be assessed when evaluating the clinical effectiveness of treatments in studies with adult cancer patients.97 The Centre for Medical Technology Policy (CMTP) panel identified 12 core symptoms which are considered the most common and distressing symptoms affecting cancer patients undergoing active treatment: “anorexia,
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anxiety, constipation, depression, diarrhoea, dyspnoea, fatigue, insomnia, nausea, pain, neuropathy and vomiting”.98(p1)
The identification of these core symptoms was supported by two systematic reviews of observational studies which focused on multi-symptom prevalence with large patient samples
in different diagnostic groups.96,99 The synthesis of findings from two systematic reviews indicates that fatigue (59.6%-62%), insomnia/disturbed sleep (41%-48.8%), pain (36%-48%) and depression and anxiety (41.3%-45%) are the most-reported symptoms among cancer patients with differing cancer diagnoses undergoing treatment.96,99 However, there are several discrepancies between the two systematic reviews in terms of findings relating to prevalence
of other symptoms, such as incontinence, cough, anorexia, dyspnoea, and difficulty concentrating The discrepancy can be explained by the differing measurements used in the studies selected for the two reviews A recent study by Cleeland et al.(2013)100 provides further evidence of the importance of focusing on this core set of symptoms, reporting a high prevalence of fatigue, disturbed sleep, pain, dry month and numbness/tingling in their sample While there is limited research in Vietnam, one published study has reported that, similar to findings from these systematic reviews, fatigue, sleep disturbance and pain are the three most common symptoms among patients with cancer in Vietnam.15
Despite the various symptom prevalence rates reported across research in this field, fatigue, pain and sleep disturbance are consistently identified as amongst the most frequent symptoms reported by cancer patients Importantly, these studies also indicate that these symptoms often occur together as a group or a cluster.96,99,101,102
Definitions of Symptom Clusters
A new direction for cancer research has emerged to reflect that cancer-related symptoms often occur as clusters One of the initial challenges in research concerning symptom clusters is the terminology used to describe this concept A cluster can be defined as
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“a number of things grouped together”.103 However, this dictionary definition does not suit the concept of symptom clusters in symptom management research, because it does not provide sufficient detail to inform clinical research and practice The pioneering researchers, Dodd et al (2001)45(p465) defined “a symptom cluster as three or more concurrent symptoms that are related to each other” Molassiotis et al (2010)9(p857) defined a symptom cluster as
“two or more symptoms that are clinically meaningful together, related to each other at a given time and share a significant variance in their cluster”
Kim et al (2005)37 suggested that the same aetiology may or may not underpin symptoms within a cluster For example, it is suggested that symptoms in a cluster can share aetiologies (e.g., treatment toxicity) or they can be caused by different aetiologies (e.g., pain from tumour growth, fatigue from treatment, sleep disturbance from hospitalisation).36 An understanding of the mechanisms underpinning the development of symptom clusters is therefore necessary to develop an intervention for symptom management that concurrently addresses multiple symptoms, as well as mediating factors between these symptoms.104Others have argued that identifying common aetiology is important, but so too is understanding the nature of symptom interrelationships that impact on a person’s overall symptom experience.105
Although there are commonalities between these published definitions in terms of the strong correlations that coexist among symptoms within the group, there are conceptual disagreements about some of the essential elements in symptom cluster definitions For example, the type and strength of interrelationships and co-occurrence has not been identified Some researchers have assessed the relationship by symptom correlations,106 while others have determined the interrelationship by the impacts of symptoms on patient outcomes.107For example, the existing research proposes that fatigue and depression are directly and indirectly associated through their relationship with functional status, 108 or the correlations
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between pain and depression reflect only part of their full relationship, which is moderated by fatigue.109 Others argue that the correlation among symptoms within clusters must be greater than the association among symptoms between different clusters.37 Researchers express varying ideas about whether a symptom is exclusively put in one unique cluster110 or can be shared between different clusters.109,111 Another controversy relates to whether there is longitudinal stability of clusters.112-114 There is also no consensus as to whether all symptoms clustered should be present at the same time.9,115These differing understandings of the symptom cluster concept, together with variations in methods and study samples in symptom cluster studies, explain some of the differing findings that are reported in symptom cluster research
Consistent with Dodd et al.’s definition,45 throughout this dissertation, a symptom cluster is defined as three or more distinct but related symptoms that are present at the same time Furthermore, the definition adopted for this study assumes that a group of symptoms within a cluster is stable, may or may not share the same aetiologies, and are relatively independent from other clusters This definition has been adopted for the present study, as it represents the most widely used in contemporary literature As it is less restrictive than other definitions, it is considered appropriate for the present study given the early state of the science in this field
Cancer-related Symptom Cluster Identification
Symptom clusters can interfere with adherence to treatments and consequently impact compliance with therapeutic regimens, and lead to treatment interruption or cessation.116Moreover, a cancer symptom cluster approach could lead to new symptom management strategies For this reason, it is important to understand the complexity of patients’ symptom cluster experiences and the factors influencing these patterns over time, in order to identify appropriate interventions and timing for implementing these interventions However, various