21 Months and older, female only, with Breast Cancer or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility and AcceptabilityPrimary· 12 weeks
The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate \> 50%), retention (follow-up assessment completion rate \> 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions \[67%\]).
The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if \>75% of participants report average satisfaction scores greater than the CSQ's mid
Feasibility - Retention at Week 12
Group
Value
95% CI
STRIDE
46
Medication Monitoring Control
47
Feasibility - Session Attendance
Group
Value
95% CI
STRIDE
45
Medication Monitoring Control
47
Acceptability
Group
Value
95% CI
STRIDE
41
Medication Monitoring Control
NA
Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study PeriodSecondary· Mean medication adherence rates over 24 weeks
Medication Event Monitoring System (MEMS Caps): Participants will store medication in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the 24-week study period between groups.
Group
Value
95% CI
STRIDE
84.75
78.80 – 90.70
Medication Monitoring Control
82.00
75.98 – 88.03
Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baselineSecondary· Baseline, and post-intervention at 12-weeks post-baseline
Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as "I stop taking my adjuvant endocrine therapy medicine for a while." Each item is answered on a scale of 1 (Always) to 5 (Never). Scores range from 5 to 25 points with scores less than 25 defined as low adherence to the m
Group
Value
95% CI
STRIDE
23.99
23.61 – 24.36
Medication Monitoring Control
23.86
23.49 – 24.23
Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.Secondary· Baseline, and post-intervention at 12-weeks post-baseline
Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 12 weeks post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. We used the satisfaction with cancer therapy subscale.
Group
Value
95% CI
STRIDE
66.53
63.82 – 69.23
Medication Monitoring Control
63.94
61.30 – 66.58
Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baselineSecondary· Baseline and post-intervention at 12 weeks post-baseline
Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 12 weeks post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (
Group
Value
95% CI
STRIDE
19.89
17.98 – 21.79
Medication Monitoring Control
20.67
18.82 – 22.53
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05535478 — Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
· NA
· completed
NCT03300336 — Optimizing Function and Independence Through STRIDE
· NA
· completed
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
NCT06148038 — CBD for Breast Cancer Primary Tumors
· Phase 1
· recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
· Phase 2
· recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
· withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg
· NA
· not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior
· NA
· not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries
· NA
· not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation
· EARLY_PHASE1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 18 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03837496.