Breast Cancer, Community Health Worker, Screening Mammography
Conditions
Brief summary
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.
Interventions
BEHAVIORALMammography with Community Health Worker (individual)
Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
BEHAVIORALMammography with Community Health Worker (group)
Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
OTHERStandard of Care Mammography
Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Women * Identifying as Hispanic ethnicity * Age 40-64 * Tennessee resident
Exclusion criteria
* Personal history of breast cancer * Current breast symptoms (palpable mass)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Measures From Interpersonal Processes of Care Survey | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Mammography Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol. | 34 |
| Mammography With Community Health Worker (Individual) Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. | 33 |
| Mammography With Community Health Worker (Group) Immediately following consent and completion of the baseline assessment, women in the intervention arm 2 will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary. | 33 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | Standard of Care Mammography | Mammography With Community Health Worker (Individual) | Mammography With Community Health Worker (Group) | Total |
|---|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 6.8 | 48.2 years STANDARD_DEVIATION 7.3 | 47.3 years STANDARD_DEVIATION 5.6 | 47.7 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 33 Participants | 33 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 34 participants | 33 participants | 33 participants | 100 participants |
| Sex: Female, Male Female | 34 Participants | 33 Participants | 33 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 34 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 33 |
Outcome results
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.
Time frame: Approximately 2 weeks after consent/screening mammogram.
Population: Participants that completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Mammography | Patient Reported Measures From Interpersonal Processes of Care Survey | 73 score on a scale |
| Mammography With Community Health Worker (Individual) | Patient Reported Measures From Interpersonal Processes of Care Survey | 78 score on a scale |
| Mammography With Community Health Worker (Group) | Patient Reported Measures From Interpersonal Processes of Care Survey | 77 score on a scale |
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.
Time frame: Baseline, approximately 2 weeks after consent/screening mammogram.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Mammography | 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. | Pre intervention | 32.5 score on a scale | Standard Deviation 5.6 |
| Standard of Care Mammography | 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. | Post Intervention | 32.7 score on a scale | Standard Deviation 4.5 |
| Mammography With Community Health Worker (Individual) | 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. | Pre intervention | 32.5 score on a scale | Standard Deviation 4.9 |
| Mammography With Community Health Worker (Individual) | 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. | Post Intervention | 33.7 score on a scale | Standard Deviation 4.6 |
| Mammography With Community Health Worker (Group) | 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. | Pre intervention | 33.6 score on a scale | Standard Deviation 5.5 |
| Mammography With Community Health Worker (Group) | 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. | Post Intervention | 33.6 score on a scale | Standard Deviation 4.6 |
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.
Time frame: Approximately 2 weeks after consent/screening mammogram.
Population: Participants that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Mammography | Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. | 74.9 score on a scale | Standard Deviation 6.6 |
| Mammography With Community Health Worker (Individual) | Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. | 78.1 score on a scale | Standard Deviation 8.6 |
| Mammography With Community Health Worker (Group) | Patient Reported Measures From the Satisfaction With Cancer Related Care Scale. | 78.8 score on a scale | Standard Deviation 5.3 |