Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05364450
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2022-05-03
Brief Title:
Facilitating Adaptive Coping with Fear of Recurrence Among Breast Cancer Survivors
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2024-09
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:
Fear of cancer recurrence FCR is a highly prevalent disruptive and under-treated problem for breast cancer survivors This randomized controlled trial will test the efficacy of group-based Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy and enhanced usual care for breast cancer survivors suffering from FCR while examining its cost-effectiveness and the mechanisms by which the intervention may work Study findings will guide the future care of breast cancer survivors with FCR
Detailed Description:
The primary objective of this 3-arm randomized control trial RCT is to build on the investigators pilot work by testing the impact of Acceptance Commitment Therapy ACT on FCR The investigators will randomly assign up to 375 early-stage Breast Cancer Survivors BCS for at least 300 study completers after attrition who have finished primary cancer treatment and who report clinically significant FCR to 1 group-based ACT 6 weekly 15-hour videoconference sessions 2 group-based Cognitive Behavioral Therapy CBT 6 weekly 15-hour videoconference sessions or 3 Enhanced Usual Care EUC a single 90-minute videoconference coaching session with self-administered readings Outcomes will be assessed at baseline and at 2 6 and 12 months additionally potential theory-driven mediators of the ACT interventions effects on key outcomes will be analyzed at these time points and at intervention midpoint Cost-effectiveness of each intervention will be assessed
Specific Aims are to 1 test the efficacy of group-based ACT compared to CBT and EUC on FCR primary outcome and anxiety depressive symptoms post-traumatic stress avoidant coping fatigue sleep disturbance and quality of life secondary outcomes in BCS with clinical FCR 2 to examine changes in psychological flexibility as a mediator of ACTs effect on FCR and 3 to perform comparative assessments of ACT CBT and EUC to determine the cost-effective intervention
Specific Aims are to 1 test the efficacy of group-based ACT compared to CBT and EUC on FCR primary outcome and anxiety depressive symptoms post-traumatic stress avoidant coping fatigue sleep disturbance and quality of life secondary outcomes in BCS with clinical FCR 2 to examine changes in psychological flexibility as a mediator of ACTs effect on FCR and 3 to perform comparative assessments of ACT CBT and EUC to determine the cost-effective intervention
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 |
|---|---|---|---|
| R01CA255480 | NIH | None | httpsreporternihgovquickSearchR01CA255480 |