Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy

Conditions

• Hormone Receptor Positive Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

21 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Aug 12, 2026

Start date

Feb 1, 2027

Status verified

Jul 2026

Primary completion

Jan 1, 2030

Completion

Jun 1, 2031

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• 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.
• 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.

Primary Outcome Measure

Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire. [ Time Frame: Up to 12 months post-baseline ]

Central Contacts

• Jamie M Jacobs, PhD
  (617) 643-1777
  [email protected]

Locations (2)

Find similar trials in Tampa, FL

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