Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Program Feasibility - Enrollment
研究概览
简要总结
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)).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with stage 4 cancer
- •Patients with impaired cognition or serious mental illness that would preclude participation in study procedures
研究组 & 干预措施
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.
干预措施: RESTORE (Behavioral)
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.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Program Feasibility - Enrollment
时间窗: 12 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 - Retention
时间窗: 12 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 Attendance
时间窗: 12 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.
次要结局
- Intervention Acceptability(12 weeks)
- Intervention Session Acceptability(12 weeks)
研究者
Kathryn E. Post, PhD, RN, ANP-BC
Principal Investigator
Massachusetts General Hospital