Trial Outcomes & Findings for Increasing African Immigrant Women's Participation in Breast Cancer Screening (NCT NCT04450264)
NCT ID: NCT04450264
Last Updated: 2024-12-13
Results Overview
Participants' intentions to complete breast cancer screening by responding to How likely or unlikely is it that you will have a mammogram in the next 12 months? 1. Very unlikely 2. Unlikely 3. Likely d 4. Very Likely
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
Immediate after the program (program average 75 minutes)
Results posted on
2024-12-13
Participant Flow
Participant milestones
| Measure |
Aim 1 Focus Group
English and French-speaking African immigrant women
|
Aim 2 Breast Cancer Education Program
African Immigrant Breast Cancer Education Program: African immigrant women are at significant risk for not participating in preventive screening, such as for breast cancer. Thus, this project will culturally adapt an existing evidenced-based, the Witness Project, by identifying potential barriers and guided by the Health Belief Model incorporate those findings into a group-based narrative education program for English and French-speaking African immigrant women. The program content will include: (1) information about the benefits of early detection of breast cancer screening, (2) education about disparities in breast cancer, (3) disparities in breast cancer screening among African immigrant women, and (4) will address the unique barriers and facilitators of African immigrant women identified in Aim 1 of this study. The program will use a culturally matched peer approach to educate and model successful experiences with mammography screening.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
85
|
|
Overall Study
COMPLETED
|
57
|
66
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
Reasons for withdrawal
| Measure |
Aim 1 Focus Group
English and French-speaking African immigrant women
|
Aim 2 Breast Cancer Education Program
African Immigrant Breast Cancer Education Program: African immigrant women are at significant risk for not participating in preventive screening, such as for breast cancer. Thus, this project will culturally adapt an existing evidenced-based, the Witness Project, by identifying potential barriers and guided by the Health Belief Model incorporate those findings into a group-based narrative education program for English and French-speaking African immigrant women. The program content will include: (1) information about the benefits of early detection of breast cancer screening, (2) education about disparities in breast cancer, (3) disparities in breast cancer screening among African immigrant women, and (4) will address the unique barriers and facilitators of African immigrant women identified in Aim 1 of this study. The program will use a culturally matched peer approach to educate and model successful experiences with mammography screening.
|
|---|---|---|
|
Overall Study
Incomplete survey
|
13
|
19
|
Baseline Characteristics
Data not collected for Aim 1
Baseline characteristics by cohort
| Measure |
Aim 1 Focus Group
n=57 Participants
English and French-speaking African immigrant women
|
Aim 2 Breast Cancer Education Program
n=66 Participants
English and French-speaking African immigrant women participating in the African Immigrant Breast Cancer Education Program
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.41 years
STANDARD_DEVIATION 9.30 • n=57 Participants
|
50.04 years
STANDARD_DEVIATION 10.27 • n=66 Participants
|
51.34 years
STANDARD_DEVIATION 9.77 • n=123 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=57 Participants
|
66 Participants
n=66 Participants
|
123 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=57 Participants
|
66 Participants
n=66 Participants
|
123 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=57 Participants
|
66 Participants
n=66 Participants
|
123 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=57 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=123 Participants
|
|
Mammogram intention
|
—
|
1.86 units on a scale
STANDARD_DEVIATION 0.35 • n=66 Participants • Data not collected for Aim 1
|
1.86 units on a scale
STANDARD_DEVIATION 0.35 • n=66 Participants • Data not collected for Aim 1
|
|
Mammogram location/appt
Yes
|
—
|
55 Participants
n=66 Participants • Data not collected for Aim 1
|
55 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Mammogram location/appt
No/Not Sure
|
—
|
11 Participants
n=66 Participants • Data not collected for Aim 1
|
11 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Perceived risk
Very Low
|
—
|
34 Participants
n=66 Participants • Data not collected for Aim 1
|
34 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Perceived risk
Somewhat Low
|
—
|
14 Participants
n=66 Participants • Data not collected for Aim 1
|
14 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Perceived risk
Moderate
|
—
|
10 Participants
n=66 Participants • Data not collected for Aim 1
|
10 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Perceived risk
Somewhat High
|
—
|
5 Participants
n=66 Participants • Data not collected for Aim 1
|
5 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Perceived risk
Very High
|
—
|
2 Participants
n=66 Participants • Data not collected for Aim 1
|
2 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Perceived risk
No response
|
—
|
1 Participants
n=66 Participants • Data not collected for Aim 1
|
1 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Comparison perceived risk
Less Likely
|
—
|
31 Participants
n=66 Participants • Data not collected for Aim 1
|
31 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Comparison perceived risk
About as Likely
|
—
|
20 Participants
n=66 Participants • Data not collected for Aim 1
|
20 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Comparison perceived risk
More Likely
|
—
|
10 Participants
n=66 Participants • Data not collected for Aim 1
|
10 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Comparison perceived risk
No response
|
—
|
5 Participants
n=66 Participants • Data not collected for Aim 1
|
5 Participants
n=66 Participants • Data not collected for Aim 1
|
|
Self-efficacy for mammogram
|
—
|
38.55 units on a scale
STANDARD_DEVIATION 9.28 • n=66 Participants • Data not collected for Aim 1
|
38.55 units on a scale
STANDARD_DEVIATION 9.28 • n=66 Participants • Data not collected for Aim 1
|
PRIMARY outcome
Timeframe: Immediate after the program (program average 75 minutes)Participants' intentions to complete breast cancer screening by responding to How likely or unlikely is it that you will have a mammogram in the next 12 months? 1. Very unlikely 2. Unlikely 3. Likely d 4. Very Likely
Outcome measures
| Measure |
Breast Cancer Education Program
n=62 Participants
English and French-speaking African immigrant women participating in the African Immigrant Breast Cancer Education Program
|
|---|---|
|
Mammogram Intention
|
1.90 score on a scale
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: Immediate after the program (program average 75 minutes)Participants' intentions to complete breast cancer screening: Have you thought about making an appointment and where you will have your next mammogram? a. Yes b. No
Outcome measures
| Measure |
Breast Cancer Education Program
n=61 Participants
English and French-speaking African immigrant women participating in the African Immigrant Breast Cancer Education Program
|
|---|---|
|
Mammogram Location and Appointment
Yes
|
55 Participants
|
|
Mammogram Location and Appointment
No/Not sure
|
6 Participants
|
SECONDARY outcome
Timeframe: Immediate after the program (program average 75 minutes)Participants' perceived risk of developing breast cancer: What do you think are the chances that you will have breast cancer at some point in your life? 1. Very low 2. Somewhat low 3. Moderate 4. Somewhat high 5. Very high
Outcome measures
| Measure |
Breast Cancer Education Program
n=62 Participants
English and French-speaking African immigrant women participating in the African Immigrant Breast Cancer Education Program
|
|---|---|
|
Perceived Risk
Very Low
|
32 Participants
|
|
Perceived Risk
Somewhat Low
|
9 Participants
|
|
Perceived Risk
Moderate
|
15 Participants
|
|
Perceived Risk
Somewhat High
|
4 Participants
|
|
Perceived Risk
Very High
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediate after the program (program average 75 minutes)Participants' perceived risk of developing breast cancer: Compared to the average person your age and gender, would you say that you are... 1. Less likely to get breast cancer 2. About as likely to get breast cancer 3. More likely to get breast cancer
Outcome measures
| Measure |
Breast Cancer Education Program
n=61 Participants
English and French-speaking African immigrant women participating in the African Immigrant Breast Cancer Education Program
|
|---|---|
|
Comparison Perceived Risk
Less Likely
|
38 Participants
|
|
Comparison Perceived Risk
As Likely
|
17 Participants
|
|
Comparison Perceived Risk
More Likely
|
6 Participants
|
SECONDARY outcome
Timeframe: Immediate after the program (program average 75 minutes)Ten items will be used to examine participants' self-efficacy for undergoing mammography using a 5-point Likert-type scale. Full scale from 10 to 50, with higher score indicating greater self-efficacy
Outcome measures
| Measure |
Breast Cancer Education Program
n=62 Participants
English and French-speaking African immigrant women participating in the African Immigrant Breast Cancer Education Program
|
|---|---|
|
Self-Efficacy for Mammography
|
40.83 score on a scale
Standard Deviation 8.24
|
Adverse Events
Aim 1 Focus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2 Breast Cancer Education Program
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. Jamilia Sly
Icahn School of Medicine at Mount Sinai
Phone: 212-824-7813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place