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Completed

NCT Number: NCT05364450

Facilitating Adaptive Coping With Fear of Recurrence Among 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.

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Key information

Conditions

Breast Neoplasm Anxiety Anxiety Disorders Breast Cancer Breast Carcinoma Breast Diseases Breast Neoplasms Cancer of Breast Fear Human Mammary Carcinoma Malignant Neoplasm of Breast Malignant Tumor of Breast Mammary Cancer Mammary Carcinoma, Human Mammary Neoplasms, Human Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University-Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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."

Other names: 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.

Other names: 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).

Other names: CBT

Primary outcomes

  1. Change in Fear of Cancer Recurrence from Baseline

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

    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.

Secondary outcomes

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

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

    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.

  2. Change in Concerns about Recurrence (CARS) from Baseline

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

    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.

  3. Fear of Cancer Recurrence Global Anchor

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

    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".

  4. Change in Anxiety Symptoms from Baseline

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

    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.

  5. Change in Anxiety from Baseline

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

    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.

  6. Change in Post-Traumatic Stress Symptoms from Baseline

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

    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.

  7. Change in Depressive Symptoms from Baseline

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

    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.

  8. Change in Depression from Baseline

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

    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.

  9. Change in Fatigue from Baseline

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

    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.

  10. Change in Sleep Disturbance from Baseline

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

    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.

  11. Change in Coping from Baseline

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

    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.

  12. Change in Quality of Life from Baseline

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

    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.

Other outcomes

  1. Change in Health-Related Quality of Life

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

    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.

  2. Direct and indirect medical and non-medical costs

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

    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.

  3. Change in Psychological Flexibility

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

    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.

  4. Change in Mindfulness

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

    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.

  5. Change in Commitment and Behavior Change

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

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Eskenazi Health
  • Indiana University Health
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 6, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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