Clinical trial · Interventional
Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
NCT07759947CI-TRIAL-00121721STRIDEnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention ('STRIDE') for improving patients' ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STRIDE | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- STRIDE Intervention
- description
- Participants randomized to STRIDE will receive a brief, manualized, videoconference intervention with six weekly one-hour sessions in small groups of two to three patients and two individual semi-structured telephone check-ins. Participants will complete questionnaires at baseline, and 3, 6, and 12 months post-baseline.
- interventionNames
- Behavioral: STRIDE
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions. Participants will also complete questionnaires at baseline, and 3, 6, and 12 months post-baseline. Participants will be offered one optional STRIDE intervention visit upon completion of the 12-month questionnaire.
- interventionNames
- Behavioral: Usual Care
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Female ≥ 21 years old * Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer * Completed primary treatment (surgery, chemotherapy, and/or radiation) * Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Ability to read and respond in English or Spanish * Distress about AET ≥ 4 on a 0-10 scale Exclusion Criteria: * Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist * Enrolled in a clinical trial for AET
References
Publications (0)
Data not yet available
No reference posted for this study.