Recruiting

A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer

The purpose of this study is to explore the feasibility and acceptability of a nurse-led, coping, and supportive care intervention for patients with triple-negative breast cancer. The intervention aims to improve psychosocial outcomes in patients with triple-negative breast cancer (e.g., quality of life (QOL), anxiety, fear of cancer recurrence (FCR)).

ClinicalTrials.gov IDNCT07513311

PhaseNA

Enrollment75

SponsorMassachusetts General Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Triple Negative Breast Cancer (TNBC)

About this study

Interventions

Behavioral: RESTORE — RESTORE is a nurse-led, small group-based, virtual (teleconference) cognitive-behavioral therapy-based intervention. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques.
Behavioral: Enhanced Usual Care — Participants will receive educational information on breast cancer survivorship care in addition to usual care.

Primary outcomes

Program Feasibility - Enrollment (12 weeks)
Program Feasibility - Retention (12 weeks)
Program Feasibility - Session Attendance (12 weeks)

Eligibility information

Inclusion Criteria: * Diagnosis of stage 1-3 triple-negative breast cancer * Age ≥ to 18 years * Between one and 12 months post curative therapy * Reporting distress at least 4/10 on a one-item screener * Ability to read and respond in English or Spanish Exclusion Criteria: * Patients with stage 4 cancer * Patients with impaired cognition or serious mental illness that would preclude participation in study procedures

Study locations

Massachusetts General Hospital, Boston, Massachusetts 02144 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.