Trial Outcomes & Findings for Promotora Navigator - Culturally Appropriate Patient Navigator (NCT NCT03557801)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

Approximately 2 weeks after consent/screening mammogram.

Results posted on

2019-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 protocol.	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.	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.
Overall Study STARTED	34	33	33
Overall Study COMPLETED	32	32	30
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 protocol.	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.	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.
Overall Study Protocol Violation	1	0	0
Overall Study Withdrawal by Subject	1	0	3
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

Promotora Navigator - Culturally Appropriate Patient Navigator

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care Mammography n=34 Participants 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.	Mammography With Community Health Worker (Individual) n=33 Participants 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.	Mammography With Community Health Worker (Group) n=33 Participants 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.	Total n=100 Participants Total of all reporting groups
Age, Continuous	47.7 years STANDARD_DEVIATION 6.8 • n=5 Participants	48.2 years STANDARD_DEVIATION 7.3 • n=7 Participants	47.3 years STANDARD_DEVIATION 5.6 • n=5 Participants	47.7 years STANDARD_DEVIATION 6.5 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants	100 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants	100 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	34 participants n=5 Participants	33 participants n=7 Participants	33 participants n=5 Participants	100 participants n=4 Participants

PRIMARY outcome

Timeframe: Approximately 2 weeks after consent/screening mammogram.

Population: Participants that completed the study.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Mammography n=32 Participants 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.	Mammography With Community Health Worker (Individual) n=32 Participants 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.	Mammography With Community Health Worker (Group) n=30 Participants 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.
Patient Reported Measures From Interpersonal Processes of Care Survey	73 score on a scale Interval 70.5 to 79.0	78 score on a scale Interval 75.0 to 84.0	77 score on a scale Interval 72.0 to 85.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard of Care Mammography n=32 Participants 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.	Mammography With Community Health Worker (Individual) n=32 Participants 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.	Mammography With Community Health Worker (Group) n=30 Participants 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.
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	32.5 score on a scale Standard Deviation 4.9	33.6 score on a scale Standard Deviation 5.5
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	33.7 score on a scale Standard Deviation 4.6	33.6 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Approximately 2 weeks after consent/screening mammogram.

Population: Participants that completed the study.

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.

Outcome measures

Outcome measures
Measure	Standard of Care Mammography n=32 Participants 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.	Mammography With Community Health Worker (Individual) n=32 Participants 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.	Mammography With Community Health Worker (Group) n=30 Participants 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.
Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.	74.9 score on a scale Standard Deviation 6.6	78.1 score on a scale Standard Deviation 8.6	78.8 score on a scale Standard Deviation 5.3

Adverse Events

Standard of Care Mammography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mammography With Community Health Worker (Individual)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mammography With Community Health Worker (Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lucy Spalluto

Vanderbilt University Medical Center

Phone: 615 343 1187

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place