Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy

NCT07759947 | Not Yet Recruiting DMC

• 2 other identifiers: 26-3431R01CA316494-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hormone Receptor Positive Breast Cancer

Keywords

Hormone Receptor Positive Breast Cancer; Adjuvant Endocrine Therapy Adherence; Coping; Supportive Care; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).

  Up to 12 months post-baseline

• Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).

  Up to 12 months post-baseline

Other Outcomes (3)

• Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).

  Up to 12 months post-baseline

• Breast cancer symptom distress as measured by the Breast Cancer Prevention Trial Checklist (BCPT).

  Up to 12 months post-baseline

• Quality of Life as measured by the Functional Assessment of Cancer Therapy (FACT-B).

  Up to 12 months post-baseline.

Study Arms (2)

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.

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.

Behavioral: Usual Care

Interventions

STRIDE BEHAVIORAL

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.

STRIDE Intervention

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Jamie M Jacobs, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie M Jacobs, PhD

CONTACT

(617) 643-1777; jjacobs@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)