Neoplasms

Nervous System Diseases

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Behaviors and Mental Disorders

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

Receiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length.

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.

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.

Acceptance and Commitment Therapy

Sophie Thomas, DClinPsy

Kathryn Powers

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.

This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist controls who will then receive ACT after the 3-month waiting period. Participants will be randomised on a 1:1 ratio to receive 12-weeks of treatment either immediately or following a 12-week wait. The treatment will be DNA-v which is a model of ACT adapted to those aged 11-24 years. The model will be further adapted for those who have undergone brain tumour treatment. As trial therapists will perform assessments, blinding is not possible. Follow-up assessments will be conducted at 12-, 24-, 36-, and 48-weeks post-randomisation with primary end point at 12-weeks.

As trial therapists will perform assessments, blinding is not possible.

Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

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

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).

The proportion of patients showing interest who then consent to the trial and complete the intervention

The session attendance rate compared to feasibility benchmarks

Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.

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.

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.

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.

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.

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.

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.

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.

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.

A patient and parent/carer-completed brief measure of behavioural and emotional functioning. Minimum score = 0; maximum score = 50. Higher scores indicate better outcome.

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.

Participant experiences of treatment as described in semi-structured qualitative interviews

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing	NCT04722237	Brain Tumors Quality of Life Brain Tumor, Pe...	Acceptance and ...	11 Years - 24 Years	Nottingham University Hospitals NHS Trust
Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing	NCT04722237	Brain Tumors Quality of Life Brain Tumor, Pe...	Acceptance and ...	11 Years - 24 Years	Nottingham University Hospitals NHS Trust

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