NCT05275361

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable breast-cancer

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

First Submitted

Initial submission to the registry

February 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 18, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

February 4, 2022

Last Update Submit

July 6, 2022

Conditions

Keywords

MammogramBreast Cancer ScreeningAfrican American women

Outcome Measures

Primary Outcomes (1)

  • 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

    -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 Outcomes (3)

  • Describe demographic characteristics of the social contacts and any associations with patient appointment attendance

    Through mammogram appointment (estimated to be 6 months)

  • Rate of mammography attendance

    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

    Through mammogram appointment (estimated to be 6 months)

Study Arms (2)

Patient: Scheduled for mammogram

EXPERIMENTAL

* Will be asked to choose 2 social contacts (adult family member or friend identified by the participant as someone who could be engaged by the research team to encourage the participant to attend her mammogram appointment) * Will receive reminder(s) from social contact about the screening mammogram appointment * Will receive reminder from Breast Health Center about screening mammogram appointment * Will be contacted to provide experience with the study

Behavioral: Social Contact Reminder

Social Contact of Patient

NO INTERVENTION

* Facilitate enrolled patient to complete the screening mammogram. * Will receive information about screening mammograms and resources available at the Breast Imaging Center. * Will be contacted approximately 3 days prior to the patient's mammogram appointment. * Will be contacted to provide experience with the study

Interventions

-The social contact will remind patient about screening mammogram appointment

Patient: Scheduled for mammogram

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • Prior history of breast cancer
  • 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
  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Whitney Hensing, M.D., M.S.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 11, 2022

Study Start

March 18, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations