Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

NCT05364450 | Completed DMC

• 2 other identifiers: 11066R01CA255480
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm; Breast Cancer; Breast Carcinoma; Malignant Neoplasm of Breast; Cancer of Breast; Mammary Neoplasms, Human; Human Mammary Carcinoma; Malignant Tumor of Breast; Mammary Cancer; Mammary Carcinoma, Human; Anxiety; Fear

Keywords

Fear of Cancer Recurrence; Fear of Cancer Return; Breast Cancer Survivor; Breast Cancer Remission

Outcome Measures

Primary Outcomes (1)

• Change in Fear of Cancer Recurrence from Baseline

  The 43-item Fear of Cancer Recurrence Inventory (FCRI) includes triggers, psychological distress, coping strategies, reassurance seeking, insight, severity, and functional impairments subscales. Each item is rated on a scale from 0 (never, not at all, or I don't think about it) to 4 (all the time or a great deal), participants indicate the extent to which they are fearful, with higher scores indicating greater FCR.

  given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

Secondary Outcomes (12)

• Change in Fear of Cancer Recurrence Questionnaire - 7 (FCR-7) from Baseline

  Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

• Change in Concerns about Recurrence (CARS) from Baseline

  Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

• Fear of Cancer Recurrence Global Anchor

  Given at 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

• Change in Anxiety Symptoms from Baseline

  Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

• Change in Anxiety from Baseline

  Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

Other Outcomes (5)

• Change in Health-Related Quality of Life

  Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

• Direct and indirect medical and non-medical costs

  Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

• Change in Psychological Flexibility

  Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

Study Arms (3)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

The EUC group will meet for a single 90-minute coaching session via Zoom Health.

Behavioral: Enhanced Usual Care

Acceptance Commitment Therapy (ACT)

ACTIVE COMPARATOR

The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Behavioral: Acceptance Commitment Therapy

Cognitive Behavioral Therapy (CBT)

ACTIVE COMPARATOR

The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.

Behavioral: Cognitive Behavioral Therapy

Interventions

Enhanced Usual Care BEHAVIORAL

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."

Also known as: EUC

Enhanced Usual Care (EUC)

Acceptance Commitment Therapy BEHAVIORAL

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.

Also known as: ACT

Acceptance Commitment Therapy (ACT)

Cognitive Behavioral Therapy BEHAVIORAL

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).

Also known as: CBT

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator
• Eskenazi Health: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Indiana University-Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders

Interventions

Acceptance and Commitment Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shelley A Johns, PsyD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An external statistician will create the randomization sequence. An unblinded research manager will maintain the randomization sequence and randomization assignment for each participant in password-protected databases not accessible by the study team. All study personnel, including the study's principal investigator (PI), biostatistician, data manager, research coordinator (RC), and research assistants (RAs), will be blind to the randomization sequence. The PI, research manager, interventionists, and intervention supervisors will be the only individuals privy to participants' randomization assignments. The study RC, RAs (including outcome assessors), and the study biostatistician and data manager will remain blind to participants' random assignments for the trial's duration to enhance rigor and reduce the risk of outcome expectancy and other biases. Participants will be blind to study hypotheses, yet will be aware of their assignment to a 6-session versus single-session intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Research Scientist

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: August 17, 2021
• Primary Completion: July 9, 2024
• Study Completion: July 9, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: A completed data set will be available in approximately May of 2025. De-identified data will be made available to qualified investigators within 6 months of acceptance of the manuscript describing major outcomes.
• Access Criteria: Investigators who request to use the de-identified dataset will be required to obtain Institutional Review Board approval and sign a data use agreement before data will be released. The data use agreement must include the following commitments: (1) use of the data will be only for their scholarly research purposes; (2) the data will be secured using appropriate computer technology (e.g., encryption, password protection) and confidentiality of the data will be maintained; (3) the data will be destroyed or returned after analyses are complete; and (4) compliance with Indiana University's Human Subjects Protection Program institutional requirements regarding handling of study data.

Locations

US (1)