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

April 6, 2026 updated by: Kathryn E. Post, PhD, RN, ANP-BC, Massachusetts General Hospital

Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) 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)).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02144
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Kathryn E Post, PhD, RN, ANP-BC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: RESTORE
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.
Active Comparator: 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.
Behavioral: Enhanced Usual Care
Participants will receive educational information on breast cancer survivorship care in addition to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathryn E Post, PhD, RN, ANP-BC, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-105
  • 1K08CA286755-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the principal investigator, Dr. Kathryn Post. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than one year following publication.

IPD Sharing Access Criteria

MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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