N/A
Completed N=100
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors
Breast Cancer · Adherence, Medication
Source: ClinicalTrials.gov NCT03837496 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Feasibility and Acceptability — 46; 47; 45; 47 Participants
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 intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Acceptability |
46; 47; 45; 47; 41; NA | — |
| SECONDARY Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period |
84.75; 82.00 | .504 |
| SECONDARY Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline |
23.99; 23.86 | .630 |
| SECONDARY Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline. |
66.53; 63.94 | .186 |
| SECONDARY Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline |
19.89; 20.67 | .562 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03837496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.