A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer

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.

• Intervention Session Acceptability [Time frame: 12 weeks]
• Changes in Symptoms of Anxiety Between Groups on the PROMIS Emotional Distress Anxiety Short Form From Baseline to 12-weeks Post-baseline. [Time frame: 12 weeks]
• Changes in Symptoms of Depression Between Groups on the PROMIS Emotional Distress Depression Short Form From Baseline to 12-weeks Post-baseline. [Time frame: 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. [Time frame: 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. [Time frame: 12 weeks]
• Changes in Fear of Cancer Recurrence Between Groups on the Fear of Cancer Recurrence-1 From Baseline to 12-weeks Post-baseline. [Time frame: 12 weeks]
• Changes in Quality of Life Between Groups at Baseline and 12-weeks Post-baseline. [Time frame: 12 weeks]
• Changes in Coping Between Groups at Baseline and 12-weeks Post-baseline. [Time frame: 12 weeks]
• Changes in Social Support Between Groups at Baseline and 12-weeks Post-baseline. [Time frame: 12 weeks]
• Changes in Fear of Recurrence and Health Concerns Between Groups at Baseline and 12-weeks Post-baseline [Time frame: 12 weeks]