Status:
COMPLETED
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Adherence, Medication
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
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 in...
Detailed Description
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 im...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03837496
Start Date
October 28 2019
End Date
December 1 2021
Last Update
November 18 2022
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114