Brain TumorsACT NOWNCT04722237
Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing
A study testing Acceptance and Commitment Therapy in people with Brain Tumors and Quality of Life, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 11 to 24 years
- Conditions the study is for
- Brain Tumors, Quality of Life, Brain Tumor, Pediatric
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2021to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sophie Thomas
Nottingham, NG7 2UH
Sophie Thomas, DClinPsy, 0115 9249924 ext. 86165, Sophie.Thomas@nhs.net
Kathryn Powers, 01159249924, Katie.Powers@nottingham.ac.uk
About this study
Official title: Acceptance and Commitment Therapy for Young Brain Tumour Survivors: An Acceptability and Feasibility Trial
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.
Read more
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.
- Conditions
- Brain Tumors, Quality of Life, Brain Tumor, Pediatric
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Cancer, Oncology, Quality of survival, children and adolescents
- Medical subject headings
- Brain Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Acceptance and Commitment Therapy | Experimental | Receiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length. Receives: Behavioral: Acceptance and Commitment Therapy |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention
Measured: assessed at 3-month follow-up
Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention
Measured: assessed at 6-month follow-up
Session attendance rate
The session attendance rate compared to feasibility benchmarks
Measured: assessed at 3-month follow-up
Session attendance rate
The session attendance rate compared to feasibility benchmarks
Measured: assessed at 6-month follow-up
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Measured: Assessed at baseline
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Measured: Assessed at session 2
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.
Measured: Assessed at 3-month follow-up.
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.
Measured: Assessed at 6-month follow-up.
Secondary outcomes (10)
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
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.
Measured: assessed at 3, 6, 9 and 12-month follow-up
Experiential interviews
Participant experiences of treatment as described in semi-structured qualitative interviews
Measured: assessed at 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start18 Mar 2021
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, University Hospitals Bristol and Weston NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University of Exeter, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Surrey, Newcastle University, University of Bristol, DNA-v International
- Responsible party
- Sponsor
- Investigators
- Sophie Thomas, DClinPsy, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722237
- Sponsor's protocol ID
- 266746
- Acronym
- ACT NOW
- Status last verified
- Aug 2023
- First submitted
- 26 Nov 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant consent will be requested for the publication of anonymised questionnaire data onto the Figshare research repository, in line with current research transparency best practice guidance (Miguel et al., 2014; Nosek et al., 2015).
Publications
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.
PubMed 34078638
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Young Brain Tumour Survivors: An Acceptability and Feasibility Trial
- ClinicalTrials.gov ID
- NCT04722237
- Acronym / sponsor ID
- ACT NOW / 266746
- Conditions
- Brain Tumors, Quality of Life, Brain Tumor, Pediatric
- Keywords
- Acceptance and Commitment Therapy, Cancer, Oncology, Quality of survival, children and adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Nottingham, University Hospitals Bristol and Weston NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, University of Exeter, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Surrey, Newcastle University, University of Bristol, DNA-v International
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyReceiving 6-to-12 weekly sessions of Acceptance and Commitment Therapy immediately after allocation. Each session will be up to one hour in length. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 11 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance 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. | Behavioural | Immediate Acceptance and Commitment Therapy |
Primary outcome
Treatment completion rate
Time frame: assessed at 3-month follow-up
The proportion of patients showing interest who then consent to the trial and complete the intervention
Treatment completion rate
Time frame: assessed at 6-month follow-up
The proportion of patients showing interest who then consent to the trial and complete the intervention
Session attendance rate
Time frame: assessed at 3-month follow-up
The session attendance rate compared to feasibility benchmarks
Session attendance rate
Time frame: assessed at 6-month follow-up
The session attendance rate compared to feasibility benchmarks
The credibility/expectancy questionnaire
Time frame: Assessed at baseline
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The credibility/expectancy questionnaire
Time frame: Assessed at session 2
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The experience of service questionnaire
Time frame: Assessed at 3-month follow-up.
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.
The experience of service questionnaire
Time frame: Assessed at 6-month follow-up.
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.
10 secondary outcomes
Acceptance and Action Questionnaire II
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Avoidance and Fusion Questionnaire for Youth 8-items
Time frame: assessed at 3, 6, 9 and 12-month follow-up
World Health Organisation wellbeing index 5-items
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Generalised Anxiety Disorder assessment 7-items
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Patient Health Questionnaire 9-items
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Euroqol 5-dimensions 3-levels
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Strengths and Difficulties Questionnaire 25-item
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Client Service Receipt Inventory
Time frame: assessed at 3, 6, 9 and 12-month follow-up
Experiential interviews
Time frame: assessed at 3- and 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 34078638Malins 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.
- Individual participant dataSharing planned: Yes. Participant consent will be requested for the publication of anonymised questionnaire data onto the Figshare research repository, in line with current research transparency best practice guidance (Miguel et al., 2014; Nosek et al., 2015).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Thomas, DClinPsy principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Brain Tumors and Quality of Life, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Thomas, DClinPsy (0115 9249924, Sophie.Thomas@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment completion rate (time frame: assessed at 3-month follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.