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Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Primary Purpose

Breast Neoplasm, Breast Cancer, Breast Carcinoma

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Enhanced Usual Care

Acceptance Commitment Therapy

Cognitive Behavioral Therapy

About this trial

This is an interventional health services research trial for Breast Neoplasm focused on measuring Fear of Cancer Recurrence, Fear of Cancer Return, Breast Cancer Survivor, Breast Cancer Remission

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Indiana University-Purdue University Indianapolis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Enhanced Usual Care (EUC)

Acceptance Commitment Therapy (ACT)

Cognitive Behavioral Therapy (CBT)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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".

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05364450

First Posted

May 3, 2022

Last Updated

July 13, 2023

Sponsor

Indiana University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05364450

Brief Title

Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 17, 2021 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

390 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Enhanced Usual Care (EUC)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Acceptance Commitment Therapy (ACT)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cognitive Behavioral Therapy (CBT)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Usual Care

Other Intervention Name(s)

EUC

Intervention Description

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."

Intervention Type

Behavioral

Intervention Name(s)

Acceptance Commitment Therapy

Other Intervention Name(s)

ACT

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Other Intervention Name(s)

CBT

Intervention Description

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).

Primary Outcome Measure Information:

Title

Change in Fear of Cancer Recurrence from Baseline

Description

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)

Secondary Outcome Measure Information:

Title

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

Description

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)

Title

Change in Concerns about Recurrence (CARS) from Baseline

Description

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.

Time Frame

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

Title

Fear of Cancer Recurrence Global Anchor

Description

Time Frame

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

Title

Change in Anxiety Symptoms from Baseline

Description

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)

Title

Change in Anxiety from Baseline

Description

Time Frame

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

Title

Change in Post-Traumatic Stress Symptoms from Baseline

Description

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.

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)

Title

Change in Depressive Symptoms from Baseline

Description

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)

Title

Change in Depression from Baseline

Description

Time Frame

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

Title

Change in Fatigue from Baseline

Description

Time Frame

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

Title

Change in Sleep Disturbance from Baseline

Description

Time Frame

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

Title

Change in Coping from Baseline

Description

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)

Title

Change in Quality of Life from Baseline

Description

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)

Other Pre-specified Outcome Measures:

Title

Change in Health-Related Quality of Life

Description

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.

Time Frame

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

Title

Direct and indirect medical and non-medical costs

Description

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.

Time Frame

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

Title

Change in Psychological Flexibility

Description

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.

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)

Title

Change in Mindfulness

Description

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.

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)

Title

Change in Commitment and Behavior Change

Description

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.

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shelley A Johns, PsyD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University-Purdue University Indianapolis

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Facilitating Adaptive Coping With Fear of Recurrence Among Breast Cancer Survivors

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