Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Nottingham University Hospitals NHS Trust72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

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

Sex: ALLMin age: 11 YearsMax age: 24 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment completion rate

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

Time frame: 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

Time frame: assessed at 6-month follow-up

Session attendance rate

The session attendance rate compared to feasibility benchmarks

Time frame: assessed at 3-month follow-up

Session attendance rate

The session attendance rate compared to feasibility benchmarks

Time frame: 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.

Time frame: Assessed at baseline

The credibility/expectancy questionnaire

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

Time frame: 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.

Time frame: Assessed at 3-month follow-up.

The experience of service questionnaire

Time frame: Assessed at 6-month follow-up.

Secondary Outcomes

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.