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Behavioral Intervention

Supportive Services for Breast Cancer (ACCESS Trial)

N/A
Recruiting
Led By Melissa Mazor
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Moderate to severe cognitive impairment
Receiving inpatient hospice care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Summary

"This trial aims to test a program to help Black and Latina women with advanced breast cancer get better support and care, as they often face challenges in accessing these services. The study will assess if the program

Who is the study for?
This trial is for women over 18 who identify as Latina or African American/Black, speak English or Spanish, and have been diagnosed with metastatic breast cancer within the last 5 years. They must be able to consent to the study. Women with moderate to severe cognitive issues, in hospice care, or already working with a community navigator can't join.
What is being tested?
The study tests a supportive care intervention delivered by community navigators for underserved Black and Latina women with metastatic breast cancer. It involves evaluating how feasible and acceptable this approach is through ACCESS Supportive Care and phone sessions.
What are the potential side effects?
Since this trial focuses on supportive services rather than medical treatments, there are no direct side effects like those associated with drugs or surgery. However, participants may experience emotional distress or discomfort during discussions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have moderate to severe difficulty with memory or thinking.
Select...
I am currently receiving care in a hospice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in The Impact of Event Scale - Revised (IES-R) scores
Change in The Memorial Symptom Assessment Scale (MSAS)
Number of participants recruited
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ACCESS Supportive CareExperimental Treatment1 Intervention
Participants randomized to the intervention arm (n=30) will be connected to the navigator to with the ACCESS Supportive care
Group II: Attention ControlPlacebo Group1 Intervention
Participants randomized to the attention control arm (n=30) will be connected with an unblinded RC .

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
534,983 Total Patients Enrolled
12 Trials studying Breast Cancer
24,267 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,829 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Melissa MazorPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
~26 spots leftby Jan 2025
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