SUrvivors' Rehabilitation Evaluation after CANcer (SURECAN)

Aims To develop, pilot and evaluate a novel, person-centred, psychological intervention ("ACT+"), 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 "survived" cancer; a third have a diminished quality of life (QoL). Poor QoL is associated with unemployment. There is a wide variation in NHS "aftercare" 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 "audit trail" 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 "pre-pilot". 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 re