Nurse-Led Support for Triple-Negative Breast Cancer Survivors
This study is testing a new nurse-led support program called RESTORE for people who have recently completed treatment for triple-negative breast cancer (TNBC). TNBC is a type of breast cancer that can be more challenging to treat. The RESTORE program is a virtual (online) group therapy that teaches coping skills, problem-solving, and relaxation techniques. Participants will either join the RESTORE program or receive educational information about breast cancer survivorship. The main goal of this study is to see if the RESTORE program is practical and well-received by patients, and if it can help improve quality of life, anxiety, and fear of cancer returning. You may be able to join if you are an adult (18 or older) diagnosed with stage 1-3 TNBC, are between one and 12 months after your curative treatment, and are experiencing some distress.
- Study design
- This study is a pilot randomized controlled trial with 75 participants. Participants will be randomly assigned to either the RESTORE program or enhanced usual care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track program feasibility, such as enrollment, retention, and session attendance, for 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Kathryn E Post, PhD, RN, ANP-BC · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Program Feasibility - Enrollment12 weeks
The investigators will evaluate program feasibility by examining enrollment metrics. Enrollment feasibility is defined as ≥ 60% of eligible, approached patients who were offered study participation enrolling in the study.
- Program Feasibility - Retention12 weeks
The investigators will evaluate program feasibility by examining retention rates. Retention feasibility is defined as ≥ 70% of participants completing the 12-week follow-up assessment.
- Program Feasibility - Session Attendance12 weeks
The investigators will evaluate program feasibility by examining session attendance. Attendance feasibility is defined as ≥ 70% of participants completing at least 4 of 5 RESTORE intervention sessions.
- Intervention Acceptability12 weeks
The investigators will evaluate intervention acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The intervention will be deemed acceptable if ≥75% of participants report average satisfaction scores above the CSQ's midpoint. The CSQ is evaluated on a 1-4 scale, with higher scores indicating greater satisfaction.