Clinical trial NCT05364450: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
name: Eskenazi Health
name: National Cancer Institute (NCI)
First posted: 2022-05-06
Enrollment: 390
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Change in Fear of Cancer Recurrence from Baseline
timeFrame: 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:
measure: Change in Fear of Cancer Recurrence Questionnaire - 7 (FCR-7) from Baseline
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Concerns about Recurrence (CARS) from Baseline
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Fear of Cancer Recurrence Global Anchor
timeFrame: Given at 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Anxiety Symptoms from Baseline
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Anxiety from Baseline
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Post-Traumatic Stress Symptoms from Baseline
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Depressive Symptoms from Baseline
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Depression from Baseline
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Fatigue from Baseline
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Sleep Disturbance from Baseline
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Coping from Baseline
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Quality of Life from Baseline
timeFrame: 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 outcomes:
measure: Change in Health-Related Quality of Life
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Direct and indirect medical and non-medical costs
timeFrame: Given at baseline (T1), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Psychological Flexibility
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Mindfulness
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
measure: Change in Commitment and Behavior Change
timeFrame: Given at baseline (T1), intervention midpoint (T-Mid), 2 months post-baseline (T2), 6 months post-baseline (T3), and 12 months post-baseline (T4)
Locations:
city: Indianapolis
country: United States
facility: Indiana University-Purdue University Indianapolis
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Shelley A Johns, PsyD
role: PRINCIPAL_INVESTIGATOR
References: