Development and feasibility testing of brief integrated rehabilitation for people with thoracic cancer

• Main Author: Bayly, Jo
• Format: Dissertation
• Language: English
• Published: King's College London 2020

Background: Worldwide, more people are diagnosed with and die from thoracic cancer (cancers of the respiratory tract, lung and pleura) than any other cancer. Most present with incurable disease and despite new advances in treatment, will be living with the consequences of advanced disease. Patients experience an array of symptoms, which impact on function and daily life. Rehabilitation aims to ameliorate the functional impairment and improve participation in daily life. Although guidelines recommend that patients should have access to rehabilitation, few cancer services integrate rehabilitation within the core treatment pathway. Aim: This study aims to develop and assess the feasibility of testing a brief integrated rehabilitation intervention for people newly diagnosed with thoracic cancer. Method: A sequential exploratory mixed methods approach, following Medical Council Guidance for the development and evaluation of complex interventions, was used to develop and test the new rehabilitation interventions. During the development phase, a systematic review explored the application of behaviour change theory and techniques in empirical rehabilitation studies in this population. Concurrently, focus groups, held with patients, family members and clinicians, elicited views on the aims, content and delivery of the proposed rehabilitation intervention. These data were integrated with reflection on theory to inform a conceptual model of brief integrated rehabilitation and set out key components, processes and outcomes of the new rehabilitation intervention. Guidelines were followed to produce an Intervention Manual to support fidelity during delivery and evaluation of the intervention in a randomised controlled feasibility trial. During the feasibility phase, participants with a recent diagnosis of lung cancer or pleural mesothelioma on any treatment pathway were recruited to a parallel group 1:1 randomised controlled multicentre feasibility trial of short-term integrated rehabilitation plus standard care versus standard care. Primary outcomes included recruitment and retention. Target recruitment was 30% of eligible participants and for more than 50% to be retained on study at 30 days. Secondary outcomes included intervention fidelity and performance of clinical outcome measuring symptoms, physical activity, self-confidence to manage disease, quality of life and health service use. A post-trial questionnaire elicited experiences of participation in the trial. A final analysis of data integrated from each phase of the study explores how the thesis aims and objectives were met. Results: Twenty-seven studies of exercise (n=15) and symptom self-management (n=12) interventions were identified in the systematic review. Application of behavioural change tools was found to be sub-optimal. Theories were used infrequently; four studies reported use of behavioural change theory and one used a symptom theory. Across studies, a mean (range) of 7 (1-18) behaviour change techniques (BCTs) were identified from intervention reports, representing 26 of 93 possible BCTs from the behaviour change techniques taxonomy vs. The most frequently identified BCTs to enable behaviour change were ‘instructions on how to perform behaviours’ (74%), ‘behavioural practice’ (74%) and ‘action planning’ (70%). BCTs to address barriers were identified less frequently and included ‘information about health consequences’ (22%), and ‘verbal persuasion about capability’ (7%) to change perceptions about benefits and harms. Fifteen clinicians (oncologists, nurse specialists, physiotherapists and occupational therapists), nine patients and five carers participated in the focus group study. A proposed outline rehabilitation model was perceived as highly relevant for this population. Participants recommendations refined the model. Prompt, brief, rehabilitation input, delivered whilst people attend for hospital appointments or at home should maximise accessibility and acceptability. Participants recognized variation in need and all prioritised tailored support for symptom self-management, daily activities and the involvement of carers. Clinicians also prioritised achieving fitness for oncology treatment. Patients and carers prioritised a sensitive manner of approach, positivity and giving hope for the future. Participant’s recommendations for outcome measurement related to confidence in usual daily activities, symptom control, and oncology treatment completion rates over objective measures of cardiorespiratory fitness. Subsequent integration of the systematic review and focus group findings with reflection on theory informed the development of a conceptual model, an intervention manual detailing rehabilitation processes and components, and a trial protocol for testing brief integrated rehabilitation in a multi-centre randomised controlled feasibility trial. The feasibility trial recruited 54 of 159 (34%) eligible patients and 44/54 (82%) and 39/54 (72%) participants provided data at 30 days and 60 days respectively. Intervention fidelity was high: 25/26 participants allocated to integrated rehabilitation received a median 3 (range 1-3) sessions of rehabilitation over 32 (22-45) days. Trial and intervention satisfaction were high. Five participants reported that the questionnaires were difficult or long to complete and two were unhappy with group allocation. Participants who received rehabilitation valued practical advice and face to face contact. Feasibility challenges included integration with oncology services, for example accessing clinic space. Changes in clinical outcomes were modest but most apparent for physical activity levels and health-related quality of life as measured by FACT-L. An estimated sample size for a future trial was calculated based on the observed changes in the FACT-L measure. Assuming a difference of 6 points, which is similar to the point estimate of effect observed, and allowing for 25% attrition, 336 participants would be required to reliably detect this difference (80% power, p=0.05) in a future efficacy trial. Conclusion: This thesis followed Medical Research Council Guidelines to develop and test a theoretically informed intervention. It found that it is feasible to recruit and retain people with thoracic cancer to a trial of brief integrated rehabilitation in the period following diagnosis. A larger trial to examine the efficacy of integrated rehabilitation in this population is feasible, with health-related quality of life as a candidate primary outcome. The conceptual model and intervention manual will be further refined during dissemination of thesis findings. Implications for clinical practice and future research are discussed and recommendations made.