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Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy

NCT07759947 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-08-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Jamie M Jacobs, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-01
Primary Completion
2030-01-01
Completion
2031-06-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759947 on ClinicalTrials.gov