Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Quality of Life Clinical Trial

— ACT NOW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722237
• Other study ID #: 266746
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: June 28, 2024

Study information

• Verified date: August 2023
• Source: Nottingham University Hospitals NHS Trust
• Contact: Sophie Thomas, DClinPsy
• Phone: 0115 9249924
• Email: Sophie.Thomas[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Pediatric
• Brain Tumors
• Neoplasms
• Quality of Life

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Sophie Thomas	Nottingham

Sponsors (10)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	DNA-v International, Great Ormond Street Hospital for Children NHS Foundation Trust, Newcastle University, Newcastle-upon-Tyne Hospitals NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, University of Bristol, University of Exeter, University of Nottingham, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion rate	The proportion of patients showing interest who then consent to the trial and complete the intervention	assessed at 3-month follow-up
Primary	Treatment completion rate	The proportion of patients showing interest who then consent to the trial and complete the intervention	assessed at 6-month follow-up
Primary	Session attendance rate	The session attendance rate compared to feasibility benchmarks	assessed at 3-month follow-up
Primary	Session attendance rate	The session attendance rate compared to feasibility benchmarks	assessed at 6-month follow-up
Primary	The credibility/expectancy questionnaire	Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.	Assessed at baseline
Primary	The credibility/expectancy questionnaire	Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.	Assessed at session 2
Primary	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.	Assessed at 3-month follow-up.
Primary	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.	Assessed at 6-month follow-up.
Secondary	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Avoidance and Fusion Questionnaire for Youth 8-items	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	World Health Organisation wellbeing index 5-items	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Generalised Anxiety Disorder assessment 7-items	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Patient Health Questionnaire 9-items	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Euroqol 5-dimensions 3-levels	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Strengths and Difficulties Questionnaire 25-item	A patient and parent/carer-completed brief measure of behavioural and emotional functioning. Minimum score = 0; maximum score = 50. Higher scores indicate better outcome.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Client Service Receipt Inventory	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.	assessed at 3, 6, 9 and 12-month follow-up
Secondary	Experiential interviews	Participant experiences of treatment as described in semi-structured qualitative interviews	assessed at 3- and 6-month follow-up