Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors
NCT ID: NCT05364450
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
390 participants
INTERVENTIONAL
2021-08-17
2024-07-09
Brief Summary
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Detailed Description
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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 ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Enhanced Usual Care (EUC)
The EUC group will meet for a single 90-minute coaching session via Zoom Health.
Enhanced Usual Care
Interventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship."
Acceptance Commitment Therapy (ACT)
The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.
Acceptance Commitment Therapy
Interventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values.
Cognitive Behavioral Therapy (CBT)
The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.
Cognitive Behavioral Therapy
Interventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance).
Interventions
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Enhanced Usual Care
Interventionists will provide a brief explanation of the intervention and coaching to the group on how to utilize the resources provided. Prior to the single session group, EUC participants will have received a workbook with the National Cancer Institute's "Facing Forward: Life After Cancer Treatment" booklet on maximizing quality of life during cancer survivorship and the American Society of Clinical Oncology's "Guide to Cancer Survivorship."
Acceptance Commitment Therapy
Interventionists will support participants in adopting a psychologically flexible posture toward FCR through six interdependent processes of change - acceptance, cognitive defusion, mindfulness, perspective taking, values, and committed action. During ACT sessions, participants will learn to respond adaptively to FCR by being more fully aware of thoughts, feelings, and bodily sensations without judging or attempting to control or avoid them. Participants will also clarify their deeply-held values and set action goals in alignment with their values.
Cognitive Behavioral Therapy
Interventionists will provide psycho-education on the cognitive behavioral model of FCR and assist participants in changing unhelpful thinking patterns and maladaptive behaviors linked to FCR. Session topics will include FCR triggers, behavioral experiments to reduce FCR-perpetuating safety behaviors, and pleasant events scheduling. Interventionists will also provide evidence-based information on behaviors that may reduce recurrence risk (e.g., achieving a healthy weight, physical activity, cancer surveillance).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
99 Years
FEMALE
No
Sponsors
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Indiana University Health
OTHER
Eskenazi Health
OTHER
National Cancer Institute (NCI)
NIH
Indiana University
OTHER
Responsible Party
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Shelley Johns
Associate Professor of Medicine, Research Scientist
Principal Investigators
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Shelley A Johns, PsyD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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11066
Identifier Type: -
Identifier Source: org_study_id