Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fear, 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

Intervention / Treatment
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* Behavioral: Enhanced Usual Care
* Behavioral: Acceptance Commitment Therapy
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fear of Cancer Recurrence, Fear of Cancer Return, Breast Cancer Survivor, Breast Cancer Remission