Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03668223
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2018-08-15
Brief Title:
The PRISM Intervention a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
The Promoting Resilience in Stress Management PRISM Intervention a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
PRISM-AC
Brief Summary:
Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management PRISM intervention among Adolescents and Young Adults with Advanced Cancer
Detailed Description:
Among patients with cancer and their families early integration of palliative care may improve quality of life This is particularly important for Adolescents and Young Adults AYAs because their distinct developmental challenges related to identity relationships and vocation may add to the burden of cancer Among AYAs with advanced cancer most understand that they may die and report that discussing end-of-life preferences goals and fears would be helpful however only 53 engage in such conversations While national guidelines call for integrated palliative care in AYA oncology developmentally targeted evidence-based interventions designed to meet psychosocial and communication needs are lacking
A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop resilience resources such as stress-management goal-setting positive reframing and meaning-making skills These resources may mitigate negative outcomes facilitate engagement in goals of care discussions and improve quality of life Furthermore promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience
Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being Over a series of studies we developed a conceptual framework of resilience in pediatric cancer affirmed associations between resilience resources and outcomes and developed a novel resilience resources intervention Promoting Resilience in Stress Management PRISM PRISM is a manualized skills-based training program comprised of four 30-60 minute in-person one-on-one sessions plus a facilitated parentcaregiverspousesignificant other family-meeting
We completed a pilot Randomized Controlled Trial RCT to test the efficacy of PRISM among 100 AYAs 6-months following their diagnosis of new n73 or recurrent n27 cancer Results suggest PRISM is feasible highly acceptable and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group raising a hypothesis to be tested in dedicated trials However qualitative feedback from patients with advanced cancer suggested refinements targeting hopes worries and contextual meaning-making might strengthen PRISMs usefulness
The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development Then we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer PRISM-AC Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care Ultimately this research has the potential to reduce the burden of cancer in a highly vulnerable population
A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop resilience resources such as stress-management goal-setting positive reframing and meaning-making skills These resources may mitigate negative outcomes facilitate engagement in goals of care discussions and improve quality of life Furthermore promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience
Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being Over a series of studies we developed a conceptual framework of resilience in pediatric cancer affirmed associations between resilience resources and outcomes and developed a novel resilience resources intervention Promoting Resilience in Stress Management PRISM PRISM is a manualized skills-based training program comprised of four 30-60 minute in-person one-on-one sessions plus a facilitated parentcaregiverspousesignificant other family-meeting
We completed a pilot Randomized Controlled Trial RCT to test the efficacy of PRISM among 100 AYAs 6-months following their diagnosis of new n73 or recurrent n27 cancer Results suggest PRISM is feasible highly acceptable and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group raising a hypothesis to be tested in dedicated trials However qualitative feedback from patients with advanced cancer suggested refinements targeting hopes worries and contextual meaning-making might strengthen PRISMs usefulness
The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development Then we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer PRISM-AC Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care Ultimately this research has the potential to reduce the burden of cancer in a highly vulnerable population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA222486 | NIH | Seattle Childrens Hospital | httpsreporternihgovquickSearchR01CA222486 |
| STUDY00001229 | OTHER | None | None |