Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors’ Rehabilitation Evaluation after CANcer (SURECAN) trial

KHAN, Imran, TAYLOR, Stephanie J. C., ROBINSON, Clare, MOSCHOPOULOU, Elisavet, MCCRONE, Paul, BOURKE, Liam, THAHA, Mohamed, BHUI, Kamaldeep, ROSARIO, Derek, RIDGE, Damien, DONOVAN, Sheila, KORSZUN, Ania, LITTLE, Paul, MORGAN, Adrienne, QUENTIN, Olivier, ROYLANCE, Rebecca, WHITE, Peter and CHALDER, Trudie (2024). Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors’ Rehabilitation Evaluation after CANcer (SURECAN) trial. Trials, 25 (1): 228.

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Abstract

: Background: Two million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise the importance of exercise and vocational activity on QoL and therefore will integrate options for physical activity and return to work/vocational support, thus ACT Plus (+). Methods: We will conduct a multi-centre, pragmatic, theory driven, randomised controlled trial. We will assess whether ACT+ including usual aftercare (intervention) is more effective and cost-effective than usual aftercare alone (control). The primary outcome is QoL of participants living with or beyond cancer measured using the Functional Assessment of Cancer Therapy: General scale (FACT-G) at 52 weeks. We will recruit 344 participants identified from secondary care sites who have completed hospital-based treatment for cancer with curative intent, with low QoL (determined by the FACT-G) and randomise with an allocation ratio of 1:1 to the intervention or control. The intervention (ACT+) will be delivered by NHS Talking Therapies, specialist services, and cancer charities. The intervention consists of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs, i.e. face-to-face sessions, over the phone or skype. Discussion: To date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families. Trial registration: ISRCTN: ISRCTN67900293. Registered on 09 December 2019. All items from the World Health Organization Trial Registration Data Set for this protocol can be found in Additional file 2 Table S1.

Item Type:	Article
Additional Information:	** From Springer Nature via Jisc Publications Router ** Licence for this article: http://creativecommons.org/licenses/by/4.0/ ** Acknowledgements: Professor Peter White was the original chief investigator and led the successful stage one (outline) Programme Grants for Applied Research (PGfAR) application. Dr. Gail Eva was one of the original co-applicants and contributed to the design of the study and the development of the intervention. We also would like to acknowledge the significant contribution to the study that is being made by the site researchers: Louise Goodwin, Lucy Colley, Marjorie Otieno, Helina Patel, Zoe Wood, Terri Burchett, Fiona Castell, Monica James, Amir Ghambari, Niroshan Rajendran, Heraa Islam, Alison Ray, Helen Mackenzie, Nicola Willis, Kristin Hunt, Jayan Jayasinghe, Shahd Mekki, and Catrin Sohrabi, in addition to the participating therapy services and their leads: John Whitehead, Chinea Eziefula, Ann Hetherington, Anna Fielden, Jon Wheatley and Shirley Coventry. We also appreciate the advice and assistance that is being offered by the patient representatives panel which include Miriam Harris, Adrienne Morgan, Moise Roche, Eldrid Herrington, Sarifa Patel, Andy Hunt, and Dave Chuter, and, finally, those who have made contributions to the study but are no longer working on SURECAN: Colin Houlihan, Zohra Zenasni, Kalia Michael, Melanie Smuk, and Camile Paulsen. **Journal IDs: eissn 1745-6215 **Article IDs: publisher-id: s13063-024-08062-4; manuscript: 8062 **History: collection 12-2024; online 02-04-2024; published_online 02-04-2024; accepted 18-03-2024; registration 18-03-2024; submitted 12-12-2023
Uncontrolled Keywords:	Acceptance and Commitment Therapy, cancer survivor, Quality of Life, Pragmatic trial
Identification Number:	https://doi.org/10.1186/s13063-024-08062-4
SWORD Depositor:	Colin Knott
Depositing User:	Colin Knott
Date Deposited:	08 Apr 2024 14:38
Last Modified:	08 Apr 2024 14:45
URI:	https://shura.shu.ac.uk/id/eprint/33518

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