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Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 11 Years - 24 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04722237
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Nottingham University Hospitals NHS Trust
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sophie Thomas, DClinPsy
Principal Investigator Affiliation Nottingham University Hospitals NHS Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOtherOtherOtherOtherOtherOther
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumors, Quality of Life, Brain Tumor, Pediatric
Arms & Interventions

Arms

Experimental: 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.

No Intervention: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nottingham University Hospitals, Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospitals

Nottingham, , NG7 2UH

Site Contact

Sam Malins, PhD

sam.malins@nottingham.ac.uk

0115 9249924 #86165