A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer
RESTORE
Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer
2 other identifiers
interventional
75
1 country
1
Brief 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)).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 7, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
April 9, 2026
April 1, 2026
2.3 years
March 23, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Program Feasibility - Enrollment
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.
12 weeks
Program Feasibility - Retention
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.
12 weeks
Program Feasibility - Session Attendance
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.
12 weeks
Intervention Acceptability
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.
12 weeks
Secondary Outcomes (10)
Intervention Session Acceptability
12 weeks
Changes in Symptoms of Anxiety Between Groups on the PROMIS Emotional Distress Anxiety Short Form From Baseline to 12-weeks Post-baseline.
12 weeks
Changes in Symptoms of Depression Between Groups on the PROMIS Emotional Distress Depression Short Form From Baseline to 12-weeks Post-baseline.
12 weeks
Changes in Symptoms of Anxiety and Depression on the Hospital Anxiety and Depression Scale Between Groups at Baseline and 12-weeks Post-baseline.
12 weeks
Changes in Fear of Cancer Recurrence Between Groups on the Fear of Cancer Recurrence Inventory - Short Form From Baseline to 12-weeks Post-baseline.
12 weeks
- +5 more secondary outcomes
Study Arms (2)
RESTORE
EXPERIMENTALRESTORE 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.
Enhanced Usual Care
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Participants will receive educational information on breast cancer survivorship care in addition to usual care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with stage 4 cancer
- Patients with impaired cognition or serious mental illness that would preclude participation in study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02144, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn E Post, PhD, RN, ANP-BC
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2026
First Posted
April 7, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
April 9, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than one year following publication.
- Access Criteria
- MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
The Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the principal investigator, Dr. Kathryn Post. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.