Nurse-led coping and support for TNBC patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study will test the feasibility and acceptability of a nurse-led coping and supportive care intervention (RESTORE) versus enhanced usual care in adults with stage 1-3 TNBC who are 1–12 months post-curative therapy and reporting distress. Participants will be randomized in a 1:1 ratio and followed for six months to assess psychosocial outcomes such as quality of life, anxiety, and fear of cancer recurrence. The trial aims to provide preliminary estimates of effect sizes to inform a larger future study. The study is funded by the National Cancer Institute and conducted at Massachusetts General Hospital, with NCI collaboration.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Kathryn E Post, PhD, RN, ANP-BC — Massachusetts General Hospital
• Study coordinator: Kathryn E Post, PhD, RN, ANP-BC
• Email: kepost@mgh.harvard.edu
• Phone: 617-726-6500

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.