Clinical trial NCT04722237: Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing
Official title: Acceptance and Commitment Therapy for Young Brain Tumour Survivors: An Acceptability and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumors
Quality of Life
Brain Tumor, Pediatric
Keywords: Acceptance and Commitment Therapy
Cancer
Oncology
Quality of survival
children and adolescents
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: University of Exeter
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: University of Surrey
name: Newcastle University
name: University of Bristol
name: DNA-v International
First posted: 2021-01-25
Enrollment: 72
Sex: ALL
Minimum age (years): 11
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment completion rate
timeFrame: assessed at 3-month follow-up
measure: Treatment completion rate
timeFrame: assessed at 6-month follow-up
measure: Session attendance rate
timeFrame: assessed at 3-month follow-up
measure: Session attendance rate
timeFrame: assessed at 6-month follow-up
measure: The credibility/expectancy questionnaire
timeFrame: Assessed at baseline
measure: The credibility/expectancy questionnaire
timeFrame: Assessed at session 2
measure: The experience of service questionnaire
timeFrame: Assessed at 3-month follow-up.
measure: The experience of service questionnaire
timeFrame: Assessed at 6-month follow-up.
Secondary outcomes:
measure: Acceptance and Action Questionnaire II
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Avoidance and Fusion Questionnaire for Youth 8-items
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: World Health Organisation wellbeing index 5-items
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Generalised Anxiety Disorder assessment 7-items
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Patient Health Questionnaire 9-items
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Euroqol 5-dimensions 3-levels
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Strengths and Difficulties Questionnaire 25-item
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Client Service Receipt Inventory
timeFrame: assessed at 3, 6, 9 and 12-month follow-up
measure: Experiential interviews
timeFrame: assessed at 3- and 6-month follow-up
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Sophie Thomas
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Sophie Thomas, DClinPsy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.