Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing
ACT NOW
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedFirst Posted
Study publicly available on registry
January 25, 2021
CompletedStudy Start
First participant enrolled
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2024
CompletedAugust 31, 2023
August 1, 2023
3.3 years
November 26, 2020
August 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention
assessed at 3-month follow-up
Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention
assessed at 6-month follow-up
Session attendance rate
The session attendance rate compared to feasibility benchmarks
assessed at 3-month follow-up
Session attendance rate
The session attendance rate compared to feasibility benchmarks
assessed at 6-month follow-up
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Assessed at baseline
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Assessed at session 2
The experience of service questionnaire
A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.
Assessed at 3-month follow-up.
The experience of service questionnaire
A questionnaire used nationally in child and adolescent mental health services completed by patients and parents/carers (if under 16) to assess participants' experience of the intervention. An additional item has been added to the experience of service questionnaire to assess video-conferencing treatment satisfaction. Minimum score = 0; maximum score = 20. Higher scores indicate better outcome.
Assessed at 6-month follow-up.
Secondary Outcomes (10)
Acceptance and Action Questionnaire II
assessed at 3, 6, 9 and 12-month follow-up
Avoidance and Fusion Questionnaire for Youth 8-items
assessed at 3, 6, 9 and 12-month follow-up
World Health Organisation wellbeing index 5-items
assessed at 3, 6, 9 and 12-month follow-up
Generalised Anxiety Disorder assessment 7-items
assessed at 3, 6, 9 and 12-month follow-up
Patient Health Questionnaire 9-items
assessed at 3, 6, 9 and 12-month follow-up
- +5 more secondary outcomes
Study Arms (2)
Immediate Acceptance and Commitment Therapy
EXPERIMENTALReceiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length.
Waitlist Control
NO INTERVENTIONReceiving no intervention during a 12-week wait, though no restrictions will be placed on the use of other services. After the wait participants will receive 6-to-12 weekly sessions of Acceptance and Commitment Therapy. Each session will be up to one hour in length.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged 11-to-24 years at the time of randomisation
- Received treatment for a brain tumour at a participating Principle Treatment Centre
- Active brain tumour treatment is complete and their condition stable for at least six-months
- Have sufficient cognitive ability to engage with ACT sessions as judged by the clinician at baseline assessment
- competent to provide informed consent (participants aged 16 or over) or assent (participants aged 11-15)
- Parent/carer competent to provide informed consent (for participants aged 11-15)
You may not qualify if:
- Received a structured behavioural intervention within six-months prior to study recruitment
- Previous or current alcohol/substance dependence, psychosis, suicidality, or eating disorder
- Moderate or severe intellectual disability, confirmed through researcher judgement at screening through questions relating to school type and previous diagnoses
- Immediate risk to self or others
- The patient or their parent/carer is not able to speak, read or write English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nottingham University Hospitals NHS Trustlead
- University of Nottinghamcollaborator
- University Hospitals Bristol and Weston NHS Foundation Trustcollaborator
- Newcastle-upon-Tyne Hospitals NHS Trustcollaborator
- University of Exetercollaborator
- Great Ormond Street Hospital for Children NHS Foundation Trustcollaborator
- University of Surreycollaborator
- Newcastle Universitycollaborator
- University of Bristolcollaborator
- DNA-v Internationalcollaborator
Study Sites (1)
Sophie Thomas
Nottingham, NG7 2UH, United Kingdom
Related Publications (1)
Malins S, Owen R, Wright I, Borrill H, Limond J, Gibson F, Grundy RG, Bailey S, Clifford SC, Lowis S, Lemon J, Hayes L, Thomas S. Acceptance and commitment therapy for young brain tumour survivors: study protocol for an acceptability and feasibility trial. BMJ Open. 2021 Jun 1;11(6):e051091. doi: 10.1136/bmjopen-2021-051091.
PMID: 34078638DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie Thomas, DClinPsy
Nottingham University Hospitals NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- As trial therapists will perform assessments, blinding is not possible.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2020
First Posted
January 25, 2021
Study Start
March 18, 2021
Primary Completion
June 28, 2024
Study Completion
June 28, 2024
Last Updated
August 31, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be published after the trial results are published.
- Access Criteria
- Data will be openly available from Figshare
Participant consent will be requested for the publication of anonymised questionnaire data onto the Figshare research repository, in line with current research transparency best practice guidance (Miguel et al., 2014; Nosek et al., 2015).