A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer
Purpose
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)).
Condition
- Triple Negative Breast Cancer (TNBC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Boston, Massachusetts 02144
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed 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 for this population. Objective: To address this gap, the proposed study, funded by the National Cancer Institute, aims to develop, refine, and pilot-test a nurse-led, coping, and supportive care intervention to address the needs of patients with TNBC as they transition from curative therapy to surveillance. Specific Aims: The aims of this project are to (1) to evaluate the feasibility and acceptability of the study protocol and intervention by conducting a pilot randomized controlled trial (RCT) of RESTORE, compared to an enhanced usual care control group (N=75), and (2) to estimate the preliminary effects of RESTORE for improving psychosocial outcomes (i.e., QOL, anxiety, FCR) in the pilot RCT. Study Design: The investigators will conduct a pilot RCT (n=75) to assess the feasibility of the intervention and an enhanced usual care group with assessments over the course of six months. The intervention is a brief, virtual, small-group, coping, and supportive care intervention that aims to improve psychosocial outcomes for patients with TNBC transitioning from curative therapy to surveillance. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be patients with early-stage TNBC. This research study involves completing a questionnaire battery at enrollment, 12 weeks, and 24 weeks. If the participants are randomized to receive the intervention, they will have five weekly 45-60-minute virtual (videoconferencing) sessions in small groups with a trained nurse, followed by two 15-minute check-in phone calls later in the study.