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

NHS Trust

Status: Enrolling

Conditions: Quality of Life; Brain Tumors; Brain Tumor, Pediatric

Treatments: Behavioral: Acceptance and Commitment Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04722237

266746

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 11 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Immediate Acceptance and Commitment Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Acceptance and Commitment Therapy

Waitlist Control

No Intervention group

Description:

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.