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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a nurse-led coping and support program is practical and acceptable for people with triple-negative breast cancer. The program aims to improve quality of life and reduce anxiety and fear that cancer will come back.

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)).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage 1–3 triple-negative breast cancer, a type that lacks three common markers used to guide treatment.
  • Are age 18 or older.
  • Finished treatment meant to cure the cancer 1–12 months ago.
  • Rate your distress at least 4 out of 10 on a one-question check.
  • Can read and answer questions in English or Spanish.

Who can't join

  • Have stage 4 cancer, which has spread to distant parts of the body.
  • Have thinking or memory problems, or a serious mental illness, that would keep you from taking part in study activities.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MA