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Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City (MARHABA)

Primary Purpose

Breast Cancer, Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SM-LHW
PN-LHW
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Muslim Americans, Patient Navigation, Breast Cancer, Cervical Cancer

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • self-identify as Muslim
  • female
  • residence in a NYC borough
  • self-report as having received a mammogram more than two years ago and are age 40-74 years
  • self-report having received a Pap test more than three years ago and are age 40-65 years

Exclusion Criteria:

  • Report a past or current diagnosis of breast or cervical cancer
  • Report having had a hysterectomy
  • Report having had breast reconstructive surgery

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LHW-led small media intervention arm (SM-LHW)

LHW-led plus small media intervention arm (PN-LHW)

Arm Description

Outcomes

Primary Outcome Measures

Awareness of Pap Test
Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?"
Awareness of Mammogram
Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?"
Pap test receipt
Pap test receipt is defined as a positive response to "Have you ever had a 'Pap test'?" after describing the test. For "no" responses, we defined Pap test intention as a positive response to "Are you planning on obtaining a 'Pap test'?"
Mammogram test receipt
Mammogram test receipt is defined as a positive response to "Have you ever had a 'Mammogram'?" after describing the test. For "no" responses, we defined Mammogram test intention as a positive response to "Are you planning on obtaining a 'Mammogram'?"

Secondary Outcome Measures

Full Information

First Posted
March 10, 2017
Last Updated
December 4, 2018
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03081507
Brief Title
Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City
Acronym
MARHABA
Official Title
Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies have reported Muslims in the US and NYC face numerous language and healthcare access barriers. This is a randomized randomized controlled design will be used to test the efficacy of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the study is to develop, implement and evaluate the efficacy of a two-arm, randomized control trial designed to increase receipt of breast and/or cervical cancer screening among Muslim women aged 40 -75 years in New York City (NYC).
Detailed Description
The goal of this study, entitled Muslim Americans Reaching for Health and Building Alliances (MARHABA), is to evaluate the effectiveness of a culturally patient navigation (PN) intervention designed for Muslim women to increase breast and cervical cancer screening participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cervical Cancer
Keywords
Muslim Americans, Patient Navigation, Breast Cancer, Cervical Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomized to an LHW-led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW) upon determination of study eligibility and informed consent procedures.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
432 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LHW-led small media intervention arm (SM-LHW)
Arm Type
Experimental
Arm Title
LHW-led plus small media intervention arm (PN-LHW)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
SM-LHW
Intervention Description
Will not receive additional follow-up from the LHW, but will be encouraged during the session to make an appointment with their provider to schedule a mammogram and Pap test, or to consult the MARHABA webpage for information on low-cost and culturally appropriate referral sources of screening. Individuals assigned to this arm who did not attend an educational seminar will be mailed a packet containing a palm card, brochure, and letter encouraging them to speak with their provider about breast and cervical cancer screening and/or going to the MARHABA webpage. LHWs will complete a follow-up survey with participants by phone or in-person at 4 months after baseline
Intervention Type
Behavioral
Intervention Name(s)
PN-LHW
Intervention Description
PNLHW participants will receive three planned contacts with LHWs that focus on navigation for obtaining mammogram and/or Pap testing.The initial contact will be made by phone and will focus on motivating participants to make an appointment with their primary care provider and/or obstetrician/gynecologist (OB/GYN), as well as provide information on low-cost or free care if necessary. The second contact will discuss the process of going to the appointment and the third contact will focus on the process of obtaining and interpreting. The second and third contacts will be either made by phone or in-person, depending on participant needs.
Primary Outcome Measure Information:
Title
Awareness of Pap Test
Description
Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?"
Time Frame
5 Months
Title
Awareness of Mammogram
Description
Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?"
Time Frame
5 Months
Title
Pap test receipt
Description
Pap test receipt is defined as a positive response to "Have you ever had a 'Pap test'?" after describing the test. For "no" responses, we defined Pap test intention as a positive response to "Are you planning on obtaining a 'Pap test'?"
Time Frame
5 Months
Title
Mammogram test receipt
Description
Mammogram test receipt is defined as a positive response to "Have you ever had a 'Mammogram'?" after describing the test. For "no" responses, we defined Mammogram test intention as a positive response to "Are you planning on obtaining a 'Mammogram'?"
Time Frame
5 Months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: self-identify as Muslim female residence in a NYC borough self-report as having received a mammogram more than two years ago and are age 40-74 years self-report having received a Pap test more than three years ago and are age 40-65 years Exclusion Criteria: Report a past or current diagnosis of breast or cervical cancer Report having had a hysterectomy Report having had breast reconstructive surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Islam
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35585475
Citation
Wyatt LC, Chebli P, Patel S, Alam G, Naeem A, Maxwell AE, Raveis VH, Ravenell J, Kwon SC, Islam NS. A Culturally Adapted Breast and Cervical Cancer Screening Intervention Among Muslim Women in New York City: Results from the MARHABA Trial. J Cancer Educ. 2023 Apr;38(2):682-690. doi: 10.1007/s13187-022-02177-5. Epub 2022 May 19.
Results Reference
derived

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Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City

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