Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07513311

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

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)).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Triple Negative Breast Cancer (TNBC) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location status: Recruiting

Location contact

Kathryn E Post, PhD, RN, ANP-BC

CONTACT

[email protected]

617-726-6500

Kathryn E Post, PhD, RN, ANP-BC

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RESTORE

Behavioral

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.

Enhanced Usual Care

Behavioral

Participants will receive educational information on breast cancer survivorship care in addition to usual care.

Primary outcomes

  1. Program Feasibility - Enrollment

    Time frame: 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.

  2. Program Feasibility - Retention

    Time frame: 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.

  3. Program Feasibility - Session Attendance

    Time frame: 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.

  4. Intervention Acceptability

    Time frame: 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.

Secondary outcomes

  1. Intervention Session Acceptability

    Time frame: 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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    Investigators will assess changes in fear of cancer recurrence using the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF). The FCRI-SF is a validated, 9-item survey assessing fear of cancer recurrence over the last month. Each item is evaluated on a 0-4 scale and a higher score reflects higher fear of cancer recurrence.

  6. 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

    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.

  7. Changes in Quality of Life Between Groups at Baseline and 12-weeks Post-baseline.

    Time frame: 12 weeks

    The investigators will assess changes in quality of life using the Functional Assessment of Cancer Therapy- Breast (FACT-B). The FACT-B is a well-validated, 37-item survey of five domains of quality of life in patients with breast cancer over the last week: physical, social, emotional, functional, well-being, and a breast cancer-specific subscale. Each item is evaluated on a 0-4 scale. Higher scores indicate greater quality of life.

  8. Changes in Coping Between Groups at Baseline and 12-weeks Post-baseline.

    Time frame: 12 weeks

    Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.

  9. Changes in Social Support Between Groups at Baseline and 12-weeks Post-baseline.

    Time frame: 12 weeks

    Investigators will assess changes in social support using the PROMIS Social Isolation Short Form. The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form is a 6-item survey evaluating perceived social support on a 5-point Likert scale. Higher scores indicate increased social support.

  10. Changes in Fear of Recurrence and Health Concerns Between Groups at Baseline and 12-weeks Post-baseline

    Time frame: 12 weeks

    Investigators will assess changes in fear about recurrence and health via the Assessment of Survivorship Concerns (ASC). The ASC is a 5-item survey scored on a 1-4 scale and includes two subscales: cancer worry and health worry. Higher scores indicate greater worry.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn E Post, PhD, RN, ANP-BC

CONTACT

[email protected]

617-726-6500

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer

Acronym: RESTORE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.