Clinical trial · Interventional
Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors
Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial
NCT03837496CI-TRIAL-00062264STRIDEcompletedN/AResults postedClinicalTrials.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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medication Monitoring Control | Other | — | UNRESOLVED |
| STRIDE | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- STRIDE Run-In
- description
- * 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
- interventionNames
- Other: STRIDE
- type
- EXPERIMENTAL
- label
- STRIDE
- description
- * 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
- interventionNames
- Other: STRIDE
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Months
Show eligibility criteria text
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)
References
Publications (3)
- DERIVEDWalsh LE, Dunderdale L, Horick N, Temel JS, Greer JA, Jacobs JM. Intervention-Related Changes in Coping Ability Drives Improvements in Mood and Quality of Life for Patients Taking Adjuvant Endocrine Therapy. Psychooncology. 2024 Dec;33(12):e70049. doi: 10.1002/pon.70049. PMID 39706803
- DERIVEDWalsh EA, Post K, Massad K, Horick N, Antoni MH, Penedo FJ, Safren SA, Partridge AH, Peppercorn J, Park ER, Temel JS, Greer JA, Jacobs JM. Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial. Breast Cancer Res Treat. 2024 Apr;204(3):547-559. doi: 10.1007/s10549-023-07228-z. Epub 2024 Jan 17. PMID 38231313
- DERIVEDJacobs JM, Rapoport CS, Horenstein A, Clay M, Walsh EA, Peppercorn J, Temel JS, Greer JA. Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. BMJ Open. 2021 Jan 4;11(1):e041626. doi: 10.1136/bmjopen-2020-041626. PMID 33397667