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)).
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
Patients with stage 4 cancer
Patients with impaired cognition or serious mental illness that would preclude participation in study procedures
Parallel
RESTORE
BehavioralRESTORE 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.
Enhanced Usual Care
BehavioralParticipants will receive educational information on breast cancer survivorship care in addition to usual care.
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.
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.
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.
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.
Intervention Session Acceptability
The investigators will assess the acceptability of intervention sessions using a 5-item survey on timing, content, and satisfaction with the RESTORE intervention. The measure is investigator-developed and is evaluated on a 1-4 scale. A higher score indicates greater acceptability of intervention sessions.
Changes in Symptoms of Anxiety Between Groups on the PROMIS Emotional Distress Anxiety Short Form From Baseline to 12-weeks Post-baseline.
The investigators will assess changes in anxiety using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress Anxiety Short Form, an 8-item survey assessing symptoms of anxiety over the last week. Each item is scored on a 1-5 scale, with higher scores indicating greater anxiety symptoms.
Changes in Symptoms of Depression Between Groups on the PROMIS Emotional Distress Depression Short Form From Baseline to 12-weeks Post-baseline.
The investigators will assess changes in depression using the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress Depression Short Form, an 8-item survey assessing symptoms of depression over the last week. Each item is evaluated on a 1-5 scale, with higher scores indicating greater depressive symptoms.
Changes in Symptoms of Anxiety and Depression on the Hospital Anxiety and Depression Scale Between Groups at Baseline and 12-weeks Post-baseline.
Investigators will assess changes in symptoms of depression and anxiety via the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, well-validated survey used widely in patients with cancer that contains two subscales assessing symptoms of depression and anxiety over the past week. Items are scored on a 0-3 scale, with higher scores indicating greater anxiety and depressive symptoms.
Changes in Fear of Cancer Recurrence Between Groups on the Fear of Cancer Recurrence-1 From Baseline to 12-weeks Post-baseline.
Investigators will assess changes in fear of cancer recurrence using the Fear of Cancer Recurrence-1 (FCR-1). The FCR-1 is a validated 1-item survey that assesses fear of cancer recurrence among cancer survivors. Participants report a score between 0 and 100, with higher scores indicating greater fear of cancer recurrence.
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
