Breast Cancer Clinical Trial
Official title:
Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting
NCT number | NCT03557801 |
Other study ID # | 180276 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 7, 2018 |
Est. completion date | October 15, 2018 |
Verified date | July 2019 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Although there has been interval improvement in reducing disparity in mammography utilization
in medically underserved communities since the 1990s, significant disparities persist and
should be addressed. In the 40-65 year old age range, there is significant disparity in
screening mammography utilization in Hispanic women compared to their white counterparts.
Culturally adapted patient-targeted healthcare interventions can help reduce ethnic
inequalities in access to cancer screening programs. Promotoras, culturally appropriate
patient navigators for the Hispanic community, have been shown to increase screening
mammography rates in the Hispanic/Latino population.
However, there is little research exploring the interaction between these lay community
health workers and community members. This proposal aims to assess this interaction by
measuring the impact of a Promotora working with community members in either a group setting
or individual setting. Understanding this interaction can lead to more effectively designed
future community interventions. Primary outcomes in this study will include women's reported
measures of interpersonal processes of care (communication and interpersonal style) during
screening mammography care, trust in the healthcare system, and satisfaction with cancer
screening care when compared to those receiving standard of care.
Status | Completed |
Enrollment | 101 |
Est. completion date | October 15, 2018 |
Est. primary completion date | October 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Women - Identifying as Hispanic ethnicity - Age 40-64 - Tennessee resident Exclusion Criteria: - Personal history of breast cancer - Current breast symptoms (palpable mass) |
Country | Name | City | State |
---|---|---|---|
United States | Matthew Walker Comprehensive Health Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Reported Measures From Interpersonal Processes of Care Survey | Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience. | Approximately 2 weeks after consent/screening mammogram. | |
Secondary | Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention. | Distrust will be measured with the Revised Healthcare System Distrust Scale. This 9 question scale is divided into two subscales: competence and values. The questions are scored on a scale from 1-5. The total score will range 5-45, with higher scores indicating higher levels of trust. Baseline distrust measured at time of initial consent/screening. Post-intervention distrust measured at time of post-survey which took place approximately 2 weeks after screening (varied as to when patient could be reached for survey). Difference in distrust is subtracts the baseline score from the post score. | Baseline, approximately 2 weeks after consent/screening mammogram. | |
Secondary | Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. | Satisfaction with care will be measured with the Patient Satisfaction with Cancer-Related Care (PSCC) Measure. This is an 18 question measure. The questions are scored on a scale from 1-5. The total score will range 5-90, higher scores indicate higher satisfaction with care. | Approximately 2 weeks after consent/screening mammogram. |
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