Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer
Massachusetts General Hospital
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)).
Description
Background: Patients with triple-negative breast cancer (TNBC) account for approximately 10-15% of all breast cancer diagnoses but are disproportionately burdened with metastatic disease and breast cancer death due to high rates of recurrence and a lack of risk-reducing treatment options in the surveillance phase. The transition to surveillance is marked with distress and prognostic uncertainty regarding fears of cancer recurrence at a time when contact with the oncology team decreases. Despite the dire needs of patients with TNBC, no coping and supportive care interventions currently exist fo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- Massachusetts General HospitalBoston, Massachusetts