Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Anxiety; Breast Neoplasm; Breast Carcinoma; Fear; Cancer of Breast; Malignant Tumor of Breast; Malignant Neoplasm of Breast; Mammary Cancer; Mammary Neoplasms, Human; Human Mammary Carcinoma; Mammary Carcinoma, Human
• Intervention / Treatment: Behavioral: Enhanced Usual Care; Behavioral: Acceptance Commitment Therapy; Behavioral: Cognitive Behavioral Therapy

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 1.5-hour videoconference sessions), (2) group-based Cognitive Behavioral Therapy (CBT; 6 weekly 1.5-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 intervention's 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 ACT's effect on FCR; and (3) to perform comparative assessments of ACT, CBT, and EUC to determine the cost-effective intervention.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University-Purdue University Indianapolis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced Usual Care (EUC); The EUC group will meet for a single 90-minute coaching session via Zoom Health.	Behavioral: 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."; Other Names: EUC
Active Comparator: Acceptance Commitment Therapy (ACT); The ACT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.	Behavioral: 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.; Other Names: ACT
Active Comparator: Cognitive Behavioral Therapy (CBT); The CBT group will meet for 90-minute sessions via Zoom Health weekly for 6 weeks.	Behavioral: 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 Names: CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fear of Cancer Recurrence Questionnaire - 7 (FCR-7) from Baseline	The 7-item FCR-7 assesses anxiety, worry, and strong feelings associated with cancer recurrence, coupled with items assessing cognitive and behavioral responses to FCR. The first six items are on a scale from 1 (not at all) to 5 (all the time). The seventh item assesses the extent to which worry about getting cancer again intrudes on thoughts and activities on a 0 (not at all) to 10 (great deal) scale. Higher scores indicate 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)
Change in Concerns about Recurrence (CARS) from Baseline	The 4-item Concerns About Recurrence Scale includes frequency, potential for upset, consistency, and intensity of fears on a 1-4 scale. Higher scores indicate greater FCR.	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	Participants will be asked "Overall, since starting your assigned study program, is your fear of cancer recurrence worse, about the same, or better?" Those rating their fear of cancer recurrence as "better" are then asked if their fear is "a little better," "somewhat better," "moderately better," "a lot better," or "completely better".	Given at 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Anxiety Symptoms from Baseline	The 7-item Generalized Anxiety Disorder Scale (GAD-7) assesses how often in the past two weeks participants have been bothered by symptoms of anxiety on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater anxiety.	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	The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety measure assesses how often participants felt various symptoms of anxiety in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater anxiety.	Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Post-Traumatic Stress Symptoms from Baseline	The 22-item Impact of Events Scale-Revised (IES-R) assesses post-traumatic distress on a 0 (not at all) to 4 (extremely) scale, with higher scores indicating greater post traumatic distress.	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 Depressive Symptoms from Baseline	The 8-item Patient Health Questionnaire (PHQ-8) depression scale assesses how often participants have been bothered with symptoms of depression over the past two weeks on a 0 (not at all) to 3 (nearly everyday) scale, with higher scores indicating greater depressive symptomatology.	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 Depression from Baseline	The 4-item PROMIS Depression measure assesses how often participants felt various symptoms of depression in the past 7 days on a 1 (never) to 5 (always) scale, with higher scores indicating greater depression severity.	Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Fatigue from Baseline	The 4-item PROMIS Fatigue measure assesses how often participants felt various symptoms of fatigue in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater fatigue severity.	Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Sleep Disturbance from Baseline	The 4-item PROMIS Sleep Disturbance measure assesses how often participants experienced aspects of sleep disturbance in the past 7 days on a 1 (not at all) to 5 (very much) scale, with higher scores indicating greater sleep disturbance.	Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Coping from Baseline	The 28-item Brief COPE assesses how often participants have been utilizing a series of coping strategies since their cancer diagnosis on a 1 (I haven't been doing this at all) to 4 (I have been doing this a lot) scale, with higher scores indicating greater use of the coping strategy.	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 Quality of Life from Baseline	The 10-item PROMIS Global Health measure assesses mental and physical health. The first nine items are on a 1 (poor or not at all) to 5 (excellent or completely) scale. The tenth item assesses average pain on a 0 (no pain) to 10 (worst pain imaginable) scale and is reverse scored. Higher scores are indicative of better global health.	Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health-Related Quality of Life	EuroQoL Five Dimensions Questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument used to estimate 'utilities' for cost-effectiveness analyses. Consists of 5 items assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 1-5 scale. An additional item asks respondents to assess overall health on a 0 (worst health imaginable) to 100 (best health imaginable) scale. This measure will be used in cost effectiveness analysis.	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	Medical and non-medical costs are measure over the past 4 weeks using the validated Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P). The first part of the TiC-P assesses frequency of use of various types of health care resources. The second part is an adaptation of the Short Form of the Health and Labor Questionnaire. This measure will be used in cost effectiveness analysis.	Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Change in Psychological Flexibility	The 18-item Cancer Acceptance and Action Questionnaire is a validated measure of cancer-related psychological flexibility, with items rated on a 1 (never true) to 7 (always true) scale. Lower scores indicate greater psychological flexibility. This measure will be used in mediator analysis.	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 Mindfulness	The 10-item Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) comprehensively assesses mindfulness processes including attention, present-focused awareness, and acceptance/non-judgment. Items are rated on a 1 (rarely or not at all) to 4 (almost always) scale, with higher scores indicating greater mindfulness. This measure will be used in mediator analysis.	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 Commitment and Behavior Change	The 5-item Value Progress subscale of the Valuing Questionnaire assesses progress in living consistently with personal values. Items are rated on a 0 (not at all true) to 6 (completely true) scale, with higher scores indicating greater values-consistent living. This measure will be used in mediator analysis.	Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Cancer Institute (NCI); Indiana University Health; Eskenazi Health
• Investigators: Principal Investigator: Shelley A Johns, PsyD, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): July 9, 2024
• Study Completion (Actual): July 9, 2024

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer Survivor; Fear of Cancer Recurrence; Fear of Cancer Return; Breast Cancer Remission
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Disease Attributes; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Neoplasms; Recurrence; Carcinoma; Breast Neoplasms; Mammary Neoplasms, Animal
• Other Study ID Numbers: 11066; R01CA255480 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NIH funded study - public database
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No