Recruiting

Supportive Care

Sponsor:

Massachusetts General Hospital

Code:

NCT07513311

Conditions

Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RESTORE

Enhanced Usual Care

Study Details

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)).

Conditions

Triple Negative Breast Cancer (TNBC)

Study ID

NCT07513311

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Enhanced Usual Care

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

Primary outcome measure

  • Program Feasibility - Enrollment [ Time Frame: 12 weeks ]
  • Program Feasibility - Retention [ Time Frame: 12 weeks ]
  • Program Feasibility - Session Attendance [ Time Frame: 12 weeks ]
  • Intervention Acceptability [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kathryn E Post, PhD, RN, ANP-BC

617-726-6500kepost@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02144

Contacts

Kathryn E Post, PhD, RN, ANP-BC

617-726-6500kepost@mgh.harvard.edu

Principal Investigator:

Kathryn E Post, PhD, RN, ANP-BC

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • triple negative breast cancer
  • coping
  • supportive care
  • nurse-led intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-15.