- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05275361
Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women
July 6, 2022 updated by: Washington University School of Medicine
Pilot Study Utilizing Social Contacts to Facilitate Mammogram Screening Among African American Women
Eliminating racial disparities in breast cancer is a top public health priority.
African American (AA) women often present with more advanced and aggressive disease at the time of diagnosis and are more likely to die from breast cancer than any other racial/ethnic group in the United States.
Mammogram screening significantly reduces breast cancer mortality by diagnosing cancer at an earlier stage where treatments are more effective.
While some AA women do not schedule screening mammograms as recommended by current guidelines, others do not show up for their exams after scheduling them (no-shows).
No-shows to cancer screening appointments impose an enormous strain on our limited healthcare resources with negative impact on other patients who could have secured earlier appointments, loss of revenue for hospitals or clinics serving underserved populations and delays in diagnoses and treatment for those who do not have screening.
The investigators identified a high no-show rate for screening mammograms at our hospital.
AA women were almost three times more likely to no-show for their mammograms compared to White women.
Patient's social networks plan an important role in health promotion.
In this study, we will pilot an intervention involving patient's social contacts (family, friends, neighbors, etc.) as healthcare facilitators to improve appointment attendance.
The investigators seek to determine whether this intervention is feasible and acceptable to patients and whether this intervention will improve attendance rates for screening mammograms among AA women at our institution.
If effective, the use of a patient's social contact person as a healthcare facilitator (similar to a patient navigator) would be a readily available and inexpensive resource for other institutions to implement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria for Patients:
- Female
- African American
- At least 40 years old
- Scheduled for a screening mammogram within 3 months following initiation of the study
- Willing and able to provide contact information for two adult social contacts (friends or family members)
Exclusion Criteria for Patients:
-Prior history of breast cancer
Inclusion Criteria for Social Contacts:
- At least 18 years old
- Selected by the patient as someone (family member or friend) who would be able to support her in keeping her mammogram appointment
Exclusion Criteria for Social Contacts:
-Less than 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient: Scheduled for mammogram
|
-The social contact will remind patient about screening mammogram appointment
|
No Intervention: Social Contact of Patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruiting patients' social contacts to serve as healthcare facilitators as measured by number of participants enrolled to the study with a social contact that agrees to participate
Time Frame: Through completion of enrollment (estimated to be 3 months)
|
-The study is deemed feasible if 80 participants are enrolled to the study and further, if at least 65% of the 80 participants will have a social contact agreeing to participate
|
Through completion of enrollment (estimated to be 3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe demographic characteristics of the social contacts and any associations with patient appointment attendance
Time Frame: Through mammogram appointment (estimated to be 6 months)
|
-Use descriptive statistics to present the characteristics of social contacts and regression analysis to determine in association with social contact characteristics and appointment attendance.
|
Through mammogram appointment (estimated to be 6 months)
|
Rate of mammography attendance
Time Frame: Through mammogram appointment (estimated to be 6 months)
|
Through mammogram appointment (estimated to be 6 months)
|
|
Using a structured survey interview, determine the percentage of patients and their social contacts who respond positively (agree or strongly agree) that the intervention helped them keep their scheduled screening mammogram appointment
Time Frame: Through mammogram appointment (estimated to be 6 months)
|
-Use descriptive statistics to present response to structured interview questions.
|
Through mammogram appointment (estimated to be 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Whitney Hensing, M.D., M.S., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
February 4, 2022
First Submitted That Met QC Criteria
March 1, 2022
First Posted (Actual)
March 11, 2022
Study Record Updates
Last Update Posted (Actual)
July 7, 2022
Last Update Submitted That Met QC Criteria
July 6, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202110124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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