Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-18

Study Completion Date

2024-06-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Brain Tumors Quality of Life Brain Tumor, Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No