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

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=75) 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, 3 months, and 6 months. The participant will also be asked to store their
hormonal therapy pills in a medication bottle provided by the study team throughout the
6-month study period. If the participants are randomized to receive the STRIDE intervention,
the participant will have five weekly one-hour virtual (videophone) or in-person sessions in
small groups with a trained clinician followed by two 15-minute check-in phone calls later in
the study. If the participants are randomized to standard care, the participant will have the
option to receive the STRIDE intervention materials after completion of their participation
in the study.

Inclusion Criteria:

- Female

- Age 21 or older

- Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer

- Within 1 week-12 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