Trial Outcomes & Findings for Empowering Latinas to Obtain Breast Cancer Screenings (NCT NCT02964234)

NCT ID: NCT02964234

Last Updated: 2021-11-18

Results Overview

Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)

Recruitment status

COMPLETED

Study phase

Target enrollment

145 participants

Primary outcome timeframe

6 months

Results posted on

2021-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Empowerment Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks	Education Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
Overall Study STARTED	76	69
Overall Study COMPLETED	54	56
Overall Study NOT COMPLETED	22	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Empowerment Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks	Education Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
Overall Study Lost to Follow-up	22	13

Baseline Characteristics

Empowering Latinas to Obtain Breast Cancer Screenings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empowerment n=76 Participants Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks	Education n=69 Participants Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks	Total n=145 Participants Total of all reporting groups
Age, Continuous	61.05 years STANDARD_DEVIATION 6.29 • n=5 Participants	61.28 years STANDARD_DEVIATION 6.36 • n=7 Participants	61.16 years STANDARD_DEVIATION 6.30 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	69 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	76 Participants n=5 Participants	69 Participants n=7 Participants	145 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants	69 participants n=7 Participants	145 participants n=5 Participants
Insurance	24 Participants n=5 Participants	40 Participants n=7 Participants	64 Participants n=5 Participants
Mammogram 4+ years ago	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Mammography intention within next year	48 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Complete case analysis used - only participants who were retained until 6 month follow-up.

Receipt of mammogram based on medical records and self report within 6 months of baseline survey (Yes or No)

Outcome measures

Outcome measures
Measure	Empowerment n=54 Participants Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks	Education n=56 Participants Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
Number of Participants Who Have Obtained Breast Cancer Screening	49 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 months

Population: This is a complete case analysis for outcome data, with all available data being used for participants who completed the 6-month follow-up.

Total scores/ranges are used. No subscales used. Knowledge - 5 items (Williams et al., 2011). Range for the change scores (baseline to 6-months) is -5 to 5. Higher scores represent a better outcome. Cultural beliefs - Ferrans cultural beliefs scale (Ferrans et al., 2007). Range for the change scores (baseline to 6-months) is -17 to 17. Higher scores represent a worse outcome. Breast cancer-specific self-efficacy - Mammography-Specific Self-Efficacy Scale (Champion, Skinner, \& Menon, 2005). Range for the change scores (baseline to 6-months) is -26 to 26. Higher scores represent a better outcome. Positive breast cancer screening norms - 6 items ( Molina et al., 2015). Range for the change scores (baseline to 6-months) is -12 to 12. Higher scores represent a better outcome. Breast cancer supportive social network size questions comprised an 8-item version of Berkman-Syme index. Range for the change scores (baseline to 6-months) is -25 to 25. Higher scores represent a better outcome.

Outcome measures

Outcome measures
Measure	Empowerment n=54 Participants Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks	Education n=56 Participants Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
Changes in Psychosocial Facilitators of Screening Survey Measures Knowledge	0.98 units on a scale Standard Deviation 1.60	1.37 units on a scale Standard Deviation 1.69
Changes in Psychosocial Facilitators of Screening Survey Measures Cultural Beliefs	-1.36 units on a scale Standard Deviation 2.94	-2.41 units on a scale Standard Deviation 3.13
Changes in Psychosocial Facilitators of Screening Survey Measures Self-Efficacy	1.02 units on a scale Standard Deviation 4.67	-1.00 units on a scale Standard Deviation 5.99
Changes in Psychosocial Facilitators of Screening Survey Measures Social Norms	0.25 units on a scale Standard Deviation 2.42	0.32 units on a scale Standard Deviation 2.94
Changes in Psychosocial Facilitators of Screening Survey Measures Supportive Network size	1.38 units on a scale Standard Deviation 4.66	5.85 units on a scale Standard Deviation 2.11

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Complete case analysis used, wherein we focus on participants who completed the 6-month follow-up surveys.

This was an open-ended questionnaire, based on the Burt Social Network Instrument. Higher numbers represent better outcomes.

Outcome measures

Outcome measures
Measure	Empowerment n=54 Participants Behavior: Empowerment Empowerment: Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks	Education n=56 Participants Behavior: Education Education: Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
Number of Individuals to Whom Participants Exchanged Information About Breast Cancer Screening.	8.27 family/friends engaged Standard Deviation 6.17	5.81 family/friends engaged Standard Deviation 12.58

Adverse Events

Empowerment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yamile Molina

University of Illinois at Chicago

Phone: 312-355-2679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place