Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing (ACT NOW)

Acceptance and Commitment Therapy for Young Brain Tumour Survivors: An Acceptability and Feasibility Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Brain Tumors; Brain Tumor, Pediatric
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Thomas, DClinPsy; Phone Number: 0115 9249924; Email: Sophie.Thomas@nhs.net
• Study Contact Backup: Name: Kathryn Powers; Phone Number: 86165 0115 9249924; Email: Katie.Powers@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2UH
    • Recruiting
    • Sophie Thomas
    • Contact: Sophie Thomas, DClinPsy; Phone Number: 86165 0115 9249924; Email: Sophie.Thomas@nhs.net
    • Contact: Kathryn Powers; Phone Number: 01159249924; Email: Katie.Powers@nottingham.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Acceptance and Commitment Therapy; Receiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length.	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.
No Intervention: Waitlist Control; Receiving 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance and Action Questionnaire II	A brief 7-item self-report measure assessing psychological inflexibility, which is the central treatment target for ACT. Validated for use among patients aged 16 and over. Minimum score = 7; maximum score = 49. Higher scores indicate worse outcome.	assessed at 3, 6, 9 and 12-month follow-up
Avoidance and Fusion Questionnaire for Youth 8-items	A brief self-report measure of psychological inflexibility, for children (11 to 15 year old participants). Minimum score = 0; maximum score = 32. Higher scores indicate worse outcome.	assessed at 3, 6, 9 and 12-month follow-up
World Health Organisation wellbeing index 5-items	A brief self-reported assessment of wellbeing and mental health. Minimum score = 7 score; maximum = 49. Higher scores indicate worse outcome. Minimum score = 0; maximum score = 49. Higher scores indicate worse outcome.	assessed at 3, 6, 9 and 12-month follow-up
Generalised Anxiety Disorder assessment 7-items	A brief self-reported measure of generalised anxiety symptoms using 4-point Likert scales based on diagnostic criteria. Minimum score = 0; maximum score = 21. Higher scores indicate worse outcome.	assessed at 3, 6, 9 and 12-month follow-up
Patient Health Questionnaire 9-items	Assesses symptoms of depression using self-reported 4-point Likert scales based on diagnostic criteria for major depression. Minimum score = 0; maximum score = 27. Higher scores indicate worse outcome.	assessed at 3, 6, 9 and 12-month follow-up
Euroqol 5-dimensions 3-levels	a self-reported assessment of five key dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The youth version will be used for participants under 16 years old. Minimum score = 0; maximum score = 1. Higher scores indicate better outcome.	assessed at 3, 6, 9 and 12-month follow-up
Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities	Assesses satisfaction with performing one's usual social roles and activities. It, therefore, acts as a measure of social engagement which can be heavily impacted by brain tumour diagnosis and treatment. Minimum score = 8; maximum score = 40. Higher scores indicate worse outcome.	assessed at 3, 6, 9 and 12-month follow-up
Strengths and Difficulties Questionnaire 25-item	A patient and parent/carer-completed brief measure of behavioural and emotional functioning. Minimum score = 0; maximum score = 50. Higher scores indicate better outcome.	assessed at 3, 6, 9 and 12-month follow-up
Client Service Receipt Inventory	A research instrument developed to collect information on service receipt, service-related issues and income. In addition, the Client Service Receipt Inventory collects information on school attendance in the 3-months prior to assessment.	assessed at 3, 6, 9 and 12-month follow-up
Experiential interviews	Participant experiences of treatment as described in semi-structured qualitative interviews	assessed at 3- and 6-month follow-up

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Collaborators: University of Nottingham; University of Bristol; Newcastle University; Newcastle-upon-Tyne Hospitals NHS Trust; University Hospitals Bristol and Weston NHS Foundation Trust; University of Exeter; Great Ormond Street Hospital for Children NHS Foundation Trust; University of Surrey; DNA-v International
• Investigators: Principal Investigator: Sophie Thomas, DClinPsy, Nottingham University Hospitals NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Estimated): June 28, 2024
• Study Completion (Estimated): June 28, 2024

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Cancer; Oncology; children and adolescents; Quality of survival
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 266746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Data will be published after the trial results are published.
• IPD Sharing Access Criteria: Data will be openly available from Figshare
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No