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

Primary Purpose

Brain Tumors, Quality of Life, Brain Tumor, Pediatric

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors focused on measuring Acceptance and Commitment Therapy, Cancer, Oncology, Quality of survival, children and adolescents

Eligibility Criteria

11 Years - 24 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Sophie ThomasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Acceptance and Commitment Therapy

Waitlist Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention
Treatment completion rate
The proportion of patients showing interest who then consent to the trial and complete the intervention
Session attendance rate
The session attendance rate compared to feasibility benchmarks
Session attendance rate
The session attendance rate compared to feasibility benchmarks
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
The credibility/expectancy questionnaire
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Experiential interviews
Participant experiences of treatment as described in semi-structured qualitative interviews

Full Information

First Posted
November 26, 2020
Last Updated
August 30, 2023
Sponsor
Nottingham University Hospitals NHS Trust
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
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1. Study Identification

Unique Protocol Identification Number
NCT04722237
Brief Title
Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing
Acronym
ACT NOW
Official Title
Acceptance and Commitment Therapy for Young Brain Tumour Survivors: An Acceptability and Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors, Quality of Life, Brain Tumor, Pediatric
Keywords
Acceptance and Commitment Therapy, Cancer, Oncology, Quality of survival, children and adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
As trial therapists will perform assessments, blinding is not possible.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Acceptance and Commitment Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment completion rate
Description
The proportion of patients showing interest who then consent to the trial and complete the intervention
Time Frame
assessed at 3-month follow-up
Title
Treatment completion rate
Description
The proportion of patients showing interest who then consent to the trial and complete the intervention
Time Frame
assessed at 6-month follow-up
Title
Session attendance rate
Description
The session attendance rate compared to feasibility benchmarks
Time Frame
assessed at 3-month follow-up
Title
Session attendance rate
Description
The session attendance rate compared to feasibility benchmarks
Time Frame
assessed at 6-month follow-up
Title
The credibility/expectancy questionnaire
Description
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Time Frame
Assessed at baseline
Title
The credibility/expectancy questionnaire
Description
Assessing participant ratings of treatment credibility. Minimum score = 5; maximum score = 45. Higher scores indicate better outcome.
Time Frame
Assessed at session 2
Title
The experience of service questionnaire
Description
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.
Time Frame
Assessed at 3-month follow-up.
Title
The experience of service questionnaire
Description
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.
Time Frame
Assessed at 6-month follow-up.
Secondary Outcome Measure Information:
Title
Acceptance and Action Questionnaire II
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Avoidance and Fusion Questionnaire for Youth 8-items
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
World Health Organisation wellbeing index 5-items
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Generalised Anxiety Disorder assessment 7-items
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Patient Health Questionnaire 9-items
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Euroqol 5-dimensions 3-levels
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Strengths and Difficulties Questionnaire 25-item
Description
A patient and parent/carer-completed brief measure of behavioural and emotional functioning. Minimum score = 0; maximum score = 50. Higher scores indicate better outcome.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Client Service Receipt Inventory
Description
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.
Time Frame
assessed at 3, 6, 9 and 12-month follow-up
Title
Experiential interviews
Description
Participant experiences of treatment as described in semi-structured qualitative interviews
Time Frame
assessed at 3- and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Thomas, DClinPsy
Phone
0115 9249924
Email
Sophie.Thomas@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Powers
Phone
0115 9249924
Ext
86165
Email
Katie.Powers@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Thomas, DClinPsy
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sophie Thomas
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Thomas, DClinPsy
Phone
0115 9249924
Ext
86165
Email
Sophie.Thomas@nhs.net
First Name & Middle Initial & Last Name & Degree
Kathryn Powers
Phone
01159249924
Email
Katie.Powers@nottingham.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
Data will be published after the trial results are published.
IPD Sharing Access Criteria
Data will be openly available from Figshare
Citations:
PubMed Identifier
34078638
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.
Results Reference
derived

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Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

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