Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405828
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-04
Brief Title:
Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Project ACCESS A Pilot Randomized Controlled Trial of a Navigator Delivered Model to Enhance Access to Supportive Services for Women of Color With Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCESS
Brief Summary:
Black and Latina women experience disparities in supportive and palliative care access and outcomes The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer
Detailed Description:
Primary Objectives
1 Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer
2 Determine the potential impact of ACCESS on cancer related distress symptom burden and utilization of supportive care services
OUTLINE Participants N60 are randomized to 1 of 2 groups
GROUP 1Intervention Group Participants complete 6 individualized behavioraleducational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months Participants complete questionnaires over the phone with a research coordinator at baseline 6 and 9 months
GROUP 2Attention Control group Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months Participants complete questionnaires over the phone with a research coordinator at baseline 6 months and 9 months
1 Establish the feasibility and acceptability of an adapted navigator delivered supportive care model called ACCESS to address supportive care needs for Black and Latina women with Metastatic Breast Cancer
2 Determine the potential impact of ACCESS on cancer related distress symptom burden and utilization of supportive care services
OUTLINE Participants N60 are randomized to 1 of 2 groups
GROUP 1Intervention Group Participants complete 6 individualized behavioraleducational sessions focused on social determinants of health and supportive care with a trained community navigator followed by monthly phone call check ins for 4 months Participants complete questionnaires over the phone with a research coordinator at baseline 6 and 9 months
GROUP 2Attention Control group Participants complete 6 phone calls with a research coordinator focused on supportive care resources followed by monthly phone call check ins for 4 months Participants complete questionnaires over the phone with a research coordinator at baseline 6 months and 9 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K08CA267309 | NIH | None | httpsreporternihgovquickSearchK08CA267309 |