Triple Negative Breast Cancer (TNBC)RESTORENCT07513311
A Nurse-Led, Coping and Supportive Intervention for Patients With Triple-Negative Breast Cancer
A study testing RESTORE in people with Triple Negative Breast Cancer (TNBC), run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- RESTORE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with stage 4 cancer
- Patients with impaired cognition or serious mental illness that would preclude participation in study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02144
Kathryn E Post, PhD, RN, ANP-BC, 617-726-6500, kepost@mgh.harvard.edu
Kathryn E Post, PhD, RN, ANP-BC
About this study
Official title: 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)).
Read the 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.
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Being tested
- RESTORE, Enhanced Usual Care
- Keywords
- triple negative breast cancer, coping, supportive care, nurse-led intervention
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTOREBehavioural
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 CareBehavioural
Participants will receive educational information on breast cancer survivorship care in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| RESTORE | Experimental | 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. Receives: Behavioral: RESTORE |
| Enhanced Usual Care | Active comparator | 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. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start7 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kathryn E. Post, PhD, RN, ANP-BC, Massachusetts General Hospital
- Investigators
- Kathryn E Post, PhD, RN, ANP-BC, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513311
- Sponsor's protocol ID
- 26-105
- Other IDs
- 1K08CA286755-01A1
- Acronym
- RESTORE
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Trial of a Nurse-Led, Coping and Supportive Intervention (RESTORE) for Patients With Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07513311
- Acronym / sponsor ID
- RESTORE / 26-105
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Keywords
- triple negative breast cancer, coping, supportive care, nurse-led intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESTORE | Experimental | Behavioral: RESTORERESTORE 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. |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with stage 4 cancer
- Patients with impaired cognition or serious mental illness that would preclude participation in study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESTORERESTORE 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. | Behavioural | RESTORE |
| Enhanced Usual CareParticipants will receive educational information on breast cancer survivorship care in addition to usual care. | Behavioural | Enhanced Usual Care |
Primary outcome
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.
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.
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.
2 secondary outcomes
Intervention Acceptability
Time frame: 12 weeks
Intervention Session Acceptability
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn E Post, PhD, RN, ANP-BC principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTORE in people with Triple Negative Breast Cancer (TNBC), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn E Post, PhD, RN, ANP-BC (617-726-6500, kepost@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Feasibility - Enrollment (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.