Title: SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN)
Funder: Department of Health and Social Care

Abstract: Aims To develop, pilot and evaluate a novel, person-centred, psychological intervention (&ldquo;ACT+&rdquo;), based on Acceptance and Commitment Therapy, for people who have completed successful treatment for cancer but experience poor quality of life. Background and rationale Two million people in the UK have &ldquo;survived&rdquo; cancer; a third have a diminished quality of life (QoL). Poor QoL is associated with unemployment. There is a wide variation in NHS &ldquo;aftercare&rdquo; and existing interventions are only moderately effective. New, effective approaches to supporting people after cancer treatment are needed. Research Plan 6 interdigitating workstreams (WS). WS 1: A qualitative meta-synthesis of cultural influences on psychological interventions for cancer survivors Research question: How can we design ACT+ to be acceptable and useful in a culturally diverse population? Methods: Meta-ethnographic synthesis based on the methods of Noblit & Hare and eMREGe reporting guidelines. Searches to include grey literature; review conducted by 2 researchers working independently; will incorporate an &ldquo;audit trail&rdquo; of decisions. WS 2: Development of Acceptance and Commitment (plus) therapy (ACT+) Research questions: What should the ACT+ intervention, materials and training be? How might the cultural adaptability and acceptability of the intervention be optimised? Methods: Preliminary versions of ACT+ manuals will be further developed. Normalisation Process Theory will underpin the conduct and interpretation of the work-stream. WS2a: Patient focus groups, including focus groups with different subcultural groups (one group will be conducted in Sylheti), individual interviews with patients, and interviews with potential therapists (IAPT high intensity therapists) and other stakeholders. WS2b: We will recruit and train therapists to deliver ACT+ sessions in a &ldquo;pre-pilot&rdquo;. Therapy sessions will be audio-recorded for analysis. Over WS2 emerging insights from the evaluation will be used to optimise ACT+ content, training, delivery and trial conduct. Analysis of data will be iterative, thematic, with constant comparison. WS 3: Pilot RCT to test recruitment and running Research question: Can we recruit and retain sufficient participants in an RCT? Methods: All WS4 trial procedures will be followed. Pilot RCT involving 45 participants across all three centres (Barts Health NHS Trust, Sheffield Teaching Hospitals NHS Foundation Trust, University College London Hospitals NHS Foundation Trust), focusing on screening, recruitment, and engagement. WS 4: Randomised controlled trial of ACT+ versus treatment as usual (TAU) Research question: Is ACT+ more effective and cost-effective than TAU in improving QoL at one year follow up? Methods: Design: pragmatic, parallel two arm, individual patient randomised trial, comparing ACT+, added to TAU, versus TAU. Setting: 344 participants recruited from hospital clinics in three centres (see WS3) Eligibility: Adults within 3 months of completing active treatment for: breast, colorectal, prostate, haematological, or head and neck cancer. Patients not fluent in English, with metastatic disease, or requiring palliative care are not eligible. Intervention: ACT+ delivered on a one to one basis (in person, via phone), by a trained therapist. Probably 3 to 6 sessions, as needed, delivered fortnightly (last session one month later). Therapists supervised by a senior clinical psychologist. Primary outcome: FACT-G (patient reported outcome measure to measure quality of life in cancer patients) at 52 weeks. Other outcomes: selection finalised in WS2, may include: IOC, HADS, Work and Social Adjustment Scale, IPAQ. Economic outcomes: EQ-5D-5L and adapted Client Service Receipt Inventory. Outcomes collected at baseline, 16 weeks and 52 weeks. Sample size: 266 participants required for effect size of 0.4 (minimally clinically important difference for FACT-G) (alpha 0.05, power 0.9). Allowing for 15% drop-out and clustering, total sample size required = 344 (172 per arm) patients. Analysis: Intention to treat principles, the main analysis will be a mixed effects linear regression model. Cost-effectiveness analysis conducted from health and social care perspectives. WS 5: Qualitative study of experience of ACT+ amongst participants and therapists Research question: How can we optimise ACT+ and its delivery? Methods: Qualitative, semi-structured interview of intervention arm participants purposively sampled on FACT-G at 20 weeks. Exit interviews with ACT+ therapists. We will use thematic analysis and constant comparison. WS 6: Therapy process evaluation Research question: What are the likely predictors, moderators and mediators of the efficacy outcome? Methods: We will measure a number of potential predictors and moderators. Mediator analysis will test single mediator models based on our logic model, mediators being measured at mid-therapy (7weeks). Projected outputs and dissemination plans Electronic newsletters, briefing reports for commissioners and UK cancer services. Dissemination through Macmillan Cancer Support. Benefits to patients and the NHS If ACT+ is both efficacious and cost-effective, the NHS will have an intervention that can improve the quality of life of the one third of cancer survivors known to have poor quality of life, and which can be given for a wide range of cancer types.

Lay abstract: Some two million people in the UK are living with or beyond cancer - &ldquo;cancer survivors&rdquo;. About a third of these patients report poor quality of life (QoL), or well-being, due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. Previous research suggests that both a talking treatment, cognitive behavioural therapy, and exercise have some effect on improving the QoL of those living with and beyond cancer; we need more effective aftercare. From talking to patients we have found that important aspects of QoL include physical abilities and psychological well-being. We surveyed cancer services to see what aftercare is provided and found most provide two sessions, given by healthcare professionals, which don t address important issues highlighted by patients. Since the best approaches are only moderately effective, we decided to adopt Acceptance and Commitment Therapy (ACT), since we thought this would provide better aftercare. ACT puts patients views about what they value most in their lives at the heart of the therapy, in order to improve their quality of life. ACT helps patients to accept what they cannot change (e.g. the cancer might recur) and commit themselves to goals they are able and want to achieve, based on their own values (e.g. becoming closer to loved ones). Since we know that exercise is helpful and work is important to many patients, we will integrate ACT with options for physical activity and work support, if these are deemed important by the patient (thus: ACT+). Because talking therapies need adapting for different cultures, we will study existing research about peoples experiences of talking therapies to understand how to make ACT+ acceptable to different ethnic and religious groups. We will develop and improve the content and delivery of ACT+ with both therapists and patients. We will determine whether sufficient numbers of patients will join a small study of ACT+, before we undertake a full study of ACT+ to see whether it improves QoL more than usual aftercare. We will also compare safety and cost-effectiveness of these two approaches, and then evaluate for whom and how it works best. From this research we will know whether ACT+ is effective, safe, culturally acceptable, and cost-effective in improving the well-being of those living with and beyond cancer. Individual patients and Macmillan Cancer Support will continue to be involved throughout the programme to help get things right from the patients perspective. We will disseminate our findings through presentations at relevant conferences and cancer charities, newsletters to our participants, and journal papers.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS