Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2021-12-01

Brief Summary

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The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.

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Detailed Description

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Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET.

Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors.

Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.

Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=100) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 12 weeks, and 24 weeks. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 24 week study period. If the participants are randomized to receive the STRIDE intervention, the participant will have six weekly one-hour virtual (videoconferencing) sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study.

Conditions

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Breast Cancer Adherence, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will be blinded to the participant's study condition

Study Groups

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STRIDE Run-In

* Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment and 3-months post- enrollment

Group Type EXPERIMENTAL

STRIDE

Intervention Type OTHER

STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

STRIDE

* Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window)
* Two 15-minute check-in phone calls later in the study
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment

Group Type EXPERIMENTAL

STRIDE

Intervention Type OTHER

STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

Medication Monitoring Control

* Medication monitoring plus standard care
* Participants will store hormonal therapy medication in a bottle provided by the study team.
* Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment

Group Type ACTIVE_COMPARATOR

Medication Monitoring Control

Intervention Type OTHER

Care provided as standard by the hospital and medication monitoring

Interventions

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STRIDE

STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

Intervention Type OTHER

Medication Monitoring Control

Care provided as standard by the hospital and medication monitoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female
* Age 21 or older
* Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer
* Within 1 week-36 months of starting adjuvant endocrine therapy
* Ability to read and respond in English
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 weeks)
* Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast cancer
* Indicates a score ≥4 on one of the three NCCN adapted distress thermometer study screening questions

Exclusion Criteria

* Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
* Cognitive impairment that prohibits participation in the study
* Enrollment in a different clinical trial for breast cancer
* Current participation in formal group psychotherapy or other psychosocial intervention trial
* Undergoing primary treatment for other cancer (i.e., advanced stage cancer)

Minimum Eligible Age

21 Months

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No