This clinical trial studies the effect of coping interventions (cognitive behavioral therapy and acceptance and commitment therapy) in supporting breast cancer survivors in managing fear of cancer coming back (recurrence). This research can help cancer survivors cope with fear of recurrence. This trial may help researchers to better understand experiences of cancer survivors and to learn how best to revise the program.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05364450.
PRIMARY OBJECTIVES:
I. To test the efficacy of group-based Acceptance and Commitment Therapy ACT compared to Cognitive Behavioral Therapy CBT and EUC on fear of cancer recurrence (FCR) (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, and quality of life (QoL) (secondary outcomes) in breast cancer survivors (BCS) with clinical FCR.
II. To examine changes in psychological flexibility as a mediator of ACT’s effect on FCR.
III. To perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive acceptance and community therapy consisting of orientation sessions over 60 minutes and 5 weekly coping skills classes over 90 minutes.
ARM II: Patients receive cognitive behavioral therapy consisting of orientation sessions over 60 minutes and 5 weekly coping skills classes over 90 minutes.
ARM III: Patients receive enhanced usual care consisting of orientation session over 60 minutes and supportive survivorship coaching over 30 minutes. Patients also receive electronic (e)-booklets.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorShelley A. Johns