Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Kathryn E Post, PhD, RN, ANP-BC
kepost@mgh.harvard.edu
617-726-6500
Time Frame
Start Date: 2026-07-07
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 75
Treatments
Experimental: RESTORE
RESTORE is delivered as five weekly one-hour virtual (teleconference) sessions in small groups with a trained nurse and two 15-minute check-in phone calls later in the study. Participants will complete questionnaires at enrollment, 12-weeks, and 24-weeks post-enrollment.
Active_comparator: Enhanced Usual Care
Participants will receive educational information on breast cancer survivorship care in addition to usual care. Participants will complete questionnaires at enrollment, 12-weeks and 24-weeks post-enrollment. Participants will be offered one optional RESTORE intervention session after completing the 24-week questionnaire.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Cancer Institute (NCI)