Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04525183
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2020-08-10
Brief Title:
REVITALIZE A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
REVITALIZE A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities
Detailed Description:
This is a two-arm multicenter pilot randomized controlled trial to compare the feasibility acceptability and preliminary efficacy of REVITALIZE a 6-week Acceptance and Commitment Therapy ACT telehealth intervention vs enhanced usual care EUC in fatigued patients with ovarian cancer on maintenance PARPi
The intervention is called REVITALIZE and it is a structured skills-based intervention for providing support knowledge and skills for coping with fatigue This type of intervention has been used in other studies to treat symptoms such as pain migraines or worry This research is being done to develop this program at the Dana-Farber Cancer Institute and the University of Pennsylvanias Abramson Cancer Center and to get patient feedback on the telehealth intervention to improve it for a future study The study is also making a preliminary determinations as to whether REVITALIZE does improve psychological flexibility and fatigue-related interference and reduce fatigue psychological distress and fear of cancer recurrence while improving overall quality of life QOL
The study will pre-pilot the REVITALIZE intervention in up to 5 patients at the Dana-Farber Cancer Institute DFCI This run-in phase serves to test and refine the newly developed 6-week ACT intervention in a smaller sample size prior to initiating the randomized control trial RCT portion of the study After the ACT intervention has been tested and refined the study will enroll and randomize 40 fatigued patients with advanced ovarian cancer on maintenance PARPi at Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of Pennsylvania
Participants will be randomized to receive either a 6-week ACT intervention or enhanced usual care educational materials The study anticipates enrolling approximately 20 patients at each site and 20 patients will be enrolled to each study arm
It is expected participants will remain in the study for the duration of the intervention and follow-up assessments which is approximately 3 months
The Funding Organization for this study is the National Comprehensive Cancer Network NCCN and the Research Funding Provider is AstraZeneca
The intervention is called REVITALIZE and it is a structured skills-based intervention for providing support knowledge and skills for coping with fatigue This type of intervention has been used in other studies to treat symptoms such as pain migraines or worry This research is being done to develop this program at the Dana-Farber Cancer Institute and the University of Pennsylvanias Abramson Cancer Center and to get patient feedback on the telehealth intervention to improve it for a future study The study is also making a preliminary determinations as to whether REVITALIZE does improve psychological flexibility and fatigue-related interference and reduce fatigue psychological distress and fear of cancer recurrence while improving overall quality of life QOL
The study will pre-pilot the REVITALIZE intervention in up to 5 patients at the Dana-Farber Cancer Institute DFCI This run-in phase serves to test and refine the newly developed 6-week ACT intervention in a smaller sample size prior to initiating the randomized control trial RCT portion of the study After the ACT intervention has been tested and refined the study will enroll and randomize 40 fatigued patients with advanced ovarian cancer on maintenance PARPi at Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of Pennsylvania
Participants will be randomized to receive either a 6-week ACT intervention or enhanced usual care educational materials The study anticipates enrolling approximately 20 patients at each site and 20 patients will be enrolled to each study arm
It is expected participants will remain in the study for the duration of the intervention and follow-up assessments which is approximately 3 months
The Funding Organization for this study is the National Comprehensive Cancer Network NCCN and the Research Funding Provider is AstraZeneca
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