RT Journal Article
SR Electronic
T1 Acceptance and commitment therapy for young brain tumour survivors: study protocol for an acceptability and feasibility trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e051091
DO 10.1136/bmjopen-2021-051091
VO 11
IS 6
A1 Sam Malins
A1 Ray Owen
A1 Ingram Wright
A1 Heather Borrill
A1 Jenny Limond
A1 Faith Gibson
A1 Richard G Grundy
A1 Simon Bailey
A1 Steven C Clifford
A1 Stephen Lowis
A1 James Lemon
A1 Louise Hayes
A1 Sophie Thomas
YR 2021
UL http://bmjopen.bmj.com/content/11/6/e051091.abstract
AB Introduction Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered acceptance and commitment therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among these young survivors.Methods and analysis This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control at 12-week follow-up as the primary endpoint. Seventy-two participants will be recruited, who are aged 11–24 and have completed brain tumour treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage at 12-week follow-up. The durability of treatment effects will be assessed by further follow-up assessments at 24 weeks, 36 weeks and 48 weeks.Ethics and dissemination Ethical approval was given by East Midlands, Nottingham 1 Research Ethics Committee (Reference: 20/EM/0237). Study results will be disseminated in peer-reviewed journals, through public events and relevant third sector organisations.Trial registration ISRCTN10903290; NCT04722237.