Hormone Receptor Positive Breast CancerSTRIDENCT07759947
Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
A study testing STRIDE in people with Hormone Receptor Positive Breast Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Hormone Receptor Positive Breast Cancer
- What is being tested?
- STRIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2027to 1 Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 21 years old
- Diagnosis of early-stage (stages zero through stage three B; 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jamie M Jacobs, PhD, (617) 643-1777, jjacobs@mgh.harvard.edu
Jamie M Jacobs, PhD
Moffitt Cancer Center
Tampa, Florida, 33612
Laura Oswald, PhD, (813) 745-1338, Laura.Oswald@moffitt.org
Laura Oswald, PhD
About this study
Official title: STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
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.
Read the detailed description
Adjuvant Endocrine Therapy (AET) is critical for most patients with hormone sensitive breast cancer. AET side effects cause distress, interfere with medication adherence, and are associated with poorer quality of life (QOL) and higher anxiety. There is a critical need to increase patients' ability to cope with AET side effects and reduce adherence barriers to AET. This project proposes to conduct a multisite randomized controlled efficacy trial in 400 patients taking AET after breast cancer to test the efficacy of STRIDE, a telehealth evidence-based behavioral intervention, compared to Usual Care (UC), for improving patients' ability to cope with AET side effects. Analyses will also examine the effect of STRIDE on patients' self-reported and objective adherence. Finally, the investigative team will explore the effects of the STRIDE intervention on mood, breast cancer symptom distress, and QOL, and whether improvements in coping ability mediate the effects of the STRIDE intervention on AET adherence.
- Conditions
- Hormone Receptor Positive Breast Cancer
- Being tested
- STRIDE, Usual Care
- Keywords
- Hormone Receptor Positive Breast Cancer, Adjuvant Endocrine Therapy Adherence, Coping, Supportive Care, Behavioral Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDEBehavioural
STRIDE is a 6-session patient-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that targets coping with and managing AET side effects. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STRIDE Intervention | Experimental | 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. Receives: Behavioral: STRIDE |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.
Measured: Up to 12 months post-baseline
Secondary outcomes (2)
Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).
Investigators will assess changes in adherence to treatment via the Medication Adherence Report Scale (MARS-5). The MARS-5 is a 5-tem survey used to measure AET adherence and suboptimal adherence behaviors. The scale consists of five items that are answered on a scale of 1-5, with higher scores indicating greater adherence to the medication.
Measured: Up to 12 months post-baseline
Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).
Participants will store medication in the Medication Event Monitoring System (MEMS Caps) 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 study period between groups.
Measured: Up to 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jamie Jacobs, Massachusetts General Hospital
- Investigators
- Jamie M Jacobs, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759947
- Sponsor's protocol ID
- 26-343
- Other IDs
- 1R01CA316494-01
- Acronym
- STRIDE
- Status last verified
- Jul 2026
- First submitted
- 7 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Harvard Cancer Consortium (HCC) encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Jamie M. Jacobs. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.