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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07513311
Status
Not Yet Recruiting

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Conditions

  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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)).

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Program Feasibility - Enrollment [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02144
Kathryn E Post, PhD, RN, ANP-BC
[email protected]
617-726-6500
Kathryn E Post, PhD, RN, ANP-BC (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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