Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy (STRIDE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hormone Receptor Positive Breast Cancer
• Intervention / Treatment: Behavioral: STRIDE; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamie M Jacobs, PhD; Phone Number: (617) 643-1777; Email: jjacobs@mgh.harvard.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
      • Principal Investigator: Laura Oswald, PhD
      • Contact: Laura Oswald, PhD; Phone Number: (813) 745-1338; Email: Laura.Oswald@moffitt.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Principal Investigator: Jamie M Jacobs, PhD
      • Contact: Jamie M Jacobs, PhD; Phone Number: (617) 643-1777; Email: jjacobs@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STRIDE Intervention; 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.	Behavioral: STRIDE; 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.
Active Comparator: Usual Care; 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.	Behavioral: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 12 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).	Investigators will assess changes in symptoms of depression and anxiety via the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, well-validated survey used widely in patients with cancer that contains two subscales assessing symptoms of depression and anxiety over the past week. Items are scored on a 0-3 scale, with higher scores indicating greater anxiety and depressive symptoms.	Up to 12 months post-baseline
Breast cancer symptom distress as measured by the Breast Cancer Prevention Trial Checklist (BCPT).	The investigators will examine changes in self-reported symptom distress using the Breast Cancer Prevention Trial Checklist (BCPT). The BCPT is a symptom checklist used to document physical and psychological symptoms associated with endocrine therapy 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 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.	Up to 12 months post-baseline
Quality of Life as measured by the Functional Assessment of Cancer Therapy (FACT-B).	Investigators will assess changes in quality of life using the Functional Assessment of Cancer Therapy- Breast (FACT-B). The FACT-B is a well-validated, 37-item survey of five domains of quality of life in patients with breast cancer over the last week: physical, social, emotional, functional, well-being, and a breast cancer-specific subscale. Each item is evaluated on a 0-4 scale. Higher scores indicate greater quality of life.	Up to 12 months post-baseline.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jamie M Jacobs, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Supportive Care; Behavioral Intervention; Coping; Hormone Receptor Positive Breast Cancer; Adjuvant Endocrine Therapy Adherence
• Other Study ID Numbers: 26-343; 1R01CA316494-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No