Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722237
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2020-11-26
Brief Title:
Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Acceptance and Commitment Therapy for Young Brain Tumour Survivors An Acceptability and Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT NOW
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None