Status:
COMPLETED
Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Indiana University Health
Eskenazi Health
Conditions:
Breast Neoplasm
Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
NA
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 Accepta...
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 w...
Eligibility Criteria
Inclusion
- Patient is ≥18 years old.
- Patient has been diagnosed with stage I-IIIA breast cancer without evidence of distant disease at time of study entry.
- Patient has completed surgery, radiation therapy, chemotherapy, and/or biologic therapy ≤5 years prior (ongoing endocrine therapy is allowed).
- Patient has clinically significant FCR (FCR-7 score ≥17 at screening).
- Patient is willing to be randomized into any of the 3 arms of the trial and attend a 6-week videoconference group if randomly assigned to ACT or CBT and a single videoconference group if randomly assigned to EUC.
- Patient is able to speak and read English
Exclusion
- Patient has a previous cancer diagnosis besides breast (non-melanoma skin cancer or melanoma in situ is allowed).
- Patient is currently participating in ACT, CBT, formal mindfulness meditation training, the "Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial," the "Thinking and Living With Cancer" study, or any other research study that has the potential to skew results of this study or the study in which the person is participating.
- Patient has co-morbidities, medications, or deficits that would impair participation in any of the 3 groups (ACT, CBT or EUC), including: history of stroke, encephalitis, traumatic brain injury/surgery, Alzheimer's disease, or other dementia; severe depressive symptoms (PHQ-2 score ≥5 at screening); active substance abuse or uncontrolled bipolar disorder, psychosis, or schizophrenia; obvious hearing and/or communicative disability.
- Patient has opted out of pre-screening for research studies (sometimes noted in the electronic medical record)
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT05364450
Start Date
August 17 2021
End Date
July 9 2024
Last Update
December 4 2024
Active Locations (1)
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1
Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, United States, 46202