RecruitingNot ApplicableNCT07513311

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

Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer


Sponsor

Massachusetts General Hospital

Enrollment

75 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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)).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • Patients with stage 4 cancer
  • Patients with impaired cognition or serious mental illness that would preclude participation in study procedures

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Interventions

BEHAVIORALRESTORE

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.

BEHAVIORALEnhanced Usual Care

Participants will receive educational information on breast cancer survivorship care in addition to usual care.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07513311


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