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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT07513311

Registry updated: 2026-09-15
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Description

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)).

Interventions

  • RESTORE (Behavioral)
    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.
  • Enhanced Usual Care (Behavioral)
    Participants will receive educational information on breast cancer survivorship care in addition to usual care.

Eligibility criteria

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

Conditions

Triple Negative Breast Cancer (TNBC)

Locations

  • Massachusetts General Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record