Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

NCT04722237 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-08-31

No results posted yet for this study

Summary

Background. 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.

Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors.

Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. 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. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically.

Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.

Conditions

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy

Acceptance and Commitment Therapy (ACT) is an evidence-based psychological therapy that has been used to improve physical and mental health among adults with health conditions, including cancer (Graham, Gouick, Krahe, \& Gillanders, 2016). It fosters engagement with, rather than avoidance of, painful experiences, to move towards acceptance of unchangeable difficulties alongside building a rich and meaningful life despite the presence of ongoing problems.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER
  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER
  • Newcastle-upon-Tyne Hospitals NHS Trust

    collaborator OTHER
  • University of Exeter

    collaborator OTHER
  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER
  • University of Surrey

    collaborator OTHER
  • Newcastle University

    collaborator OTHER
  • University of Bristol

    collaborator OTHER
  • DNA-v International

    collaborator UNKNOWN
  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Sophie Thomas, DClinPsy · Nottingham University Hospitals NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2024-06-28
Completion
2024-06-28

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04722237 on ClinicalTrials.gov