Supportive Care for Breast Cancer

(RESTORE Trial)

Overseen By Kathryn E Post, PhD, RN, ANP-BC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Stage 4 cancer, impaired cognition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

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)).

Who Is on the Research Team?

Kathryn E Post, PhD, RN, ANP-BC

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Reporting distress at least 4/10 on a one-item screener

Ability to read and respond in English or Spanish

I have stage 1-3 triple-negative breast cancer.

Exclusion Criteria

Patients with impaired cognition or serious mental illness that would preclude participation in study procedures

I have stage 4 cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the RESTORE intervention, consisting of five weekly virtual sessions and two follow-up phone calls

5 weeks

5 virtual sessions, 2 phone calls

Follow-up

Participants are monitored for psychosocial outcomes and complete questionnaires at 12 and 24 weeks post-enrollment

24 weeks

Questionnaires at 12 and 24 weeks

Optional RESTORE Session

Participants in the Enhanced Usual Care group are offered one optional RESTORE intervention session after completing the 24-week questionnaire

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• RESTORE

How Is the Trial Designed?

Group I: RESTORE Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+