Triple Negative Breast Cancer (TNBC)
Conditions
Keywords
triple negative breast cancer, coping, supportive care, nurse-led intervention
Brief 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)).
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.
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.
Sponsors
Massachusetts General Hospital
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Program Feasibility - Enrollment | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability | 12 weeks | 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 | 12 weeks | 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. |
Countries
United States
Contacts
CONTACTKathryn E Post, PhD, RN, ANP-BC
PRINCIPAL_INVESTIGATORKathryn E Post, PhD, RN, ANP-BC
Massachusetts General Hospital
Outcome results
None listed