NCT03081507

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2018

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

1.6 years

First QC Date

March 10, 2017

Last Update Submit

December 4, 2018

Conditions

Keywords

Muslim AmericansPatient NavigationBreast CancerCervical Cancer

Outcome Measures

Primary Outcomes (4)

  • Awareness of Pap Test

    Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?"

    5 Months

  • Awareness of Mammogram

    Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?"

    5 Months

  • 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'?"

    5 Months

  • 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'?"

    5 Months

Study Arms (2)

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

EXPERIMENTAL
Behavioral: SM-LHW

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

EXPERIMENTAL
Behavioral: PN-LHW

Interventions

SM-LHWBEHAVIORAL

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

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

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.

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

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10017, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Nadia Islam

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

March 1, 2017

Primary Completion

September 20, 2018

Study Completion

September 28, 2018

Last Updated

December 5, 2018

Record last verified: 2018-12

Locations