NCT03557801

Promotora Navigator - Culturally Appropriate Patient Navigator

Completed NA Results posted Last updated 14 August 2019

What this trial tests

NA trial testing Mammography with Community Health Worker (individual) in Breast Cancer in 101 participants. Completed in 15 October 2018.

Timeline

7 June 2018

Primary endpoint
15 October 2018

15 October 2018

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	101
Start date	7 June 2018
Primary completion	15 October 2018
Estimated completion	15 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Mammography with Community Health Worker (individual)
• Mammography with Community Health Worker (group)
• Standard of Care Mammography

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Screening Mammography — all drugs for Screening Mammography →
• Community Health Worker — all drugs for Community Health Worker →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 40 to 64, female only, with Breast Cancer or Screening Mammography. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Reported Measures From Interpersonal Processes of Care Survey Primary · Approximately 2 weeks after consent/screening mammogram.

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.

Group	Value	95% CI
Standard of Care Mammography	73	70.5 – 79
Mammography With Community Health Worker (Individual)	78	75 – 84
Mammography With Community Health Worker (Group)	77	72 – 85

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. Secondary · Baseline, approximately 2 weeks after consent/screening mammogram.

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.

Pre intervention

Group	Value	95% CI
Standard of Care Mammography	32.5	± 5.6
Mammography With Community Health Worker (Individual)	32.5	± 4.9
Mammography With Community Health Worker (Group)	33.6	± 5.5

Post Intervention

Group	Value	95% CI
Standard of Care Mammography	32.7	± 4.5
Mammography With Community Health Worker (Individual)	33.7	± 4.6
Mammography With Community Health Worker (Group)	33.6	± 4.6

Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. Secondary · Approximately 2 weeks after consent/screening mammogram.

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.

Group	Value	95% CI
Standard of Care Mammography	74.9	± 6.6
Mammography With Community Health Worker (Individual)	78.1	± 8.6
Mammography With Community Health Worker (Group)	78.8	± 5.3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Community-Academic Partnership to Reduce Health Care Disparities in Diagnostic Imaging.
   Spalluto LB, Thomas D, Beard KR, Campbell T, et al · · 2019 · cited 14× · PMID 30947902 · DOI 10.1016/j.jacr.2018.12.033