Trial Outcomes & Findings for Intervention to Promote Breast Cancer Screening Among American Indian Women (NCT NCT05530603)

Last Updated: 2025-03-17

Results Overview

This outcome was assessed based on the number of participants who reported having received a mammogram during the six-month follow-up survey. The survey asked participants, "Have you ever received a mammogram since you had participated in a mammogram intervention?" Participants could respond with either "Yes, I have received one" or "No, I haven't received one yet." We calculated and compared the number of participants from each arm who received mammograms after the intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

133 participants

Primary outcome timeframe

Week 24

Results posted on

2025-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Overall Study STARTED	66	67
Overall Study COMPLETED	62	60
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervention to Promote Breast Cancer Screening Among American Indian Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=66 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=67 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.	Total n=133 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	56 Participants n=7 Participants	115 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	50.50 years n=5 Participants	55.37 years n=7 Participants	52.89 years n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (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	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Receipt of Mammogram	26 Participants n=5 Participants	12 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Number of Participants Who Received a Mammogram	26 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline and Week 1

Participants' breast cancer knowledge levels were assessed using the Breast Cancer Knowledge Test, which includes 28 true- or false-items. Scores were determined by the number of correct responses, with the total score ranging from 0 to 28. Higher scores indicate greater breast cancer knowledge, with a score of 0 reflecting no knowledge and a score of 28 indicating very high knowledge. The test was updated to align with the latest American Cancer Society breast cancer screening guideline. Change = (Week 1 Score - Baseline Score).

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Change in Participants' Breast Cancer Knowledge Levels From Baseline to Week 1	22.95 units on a scale Standard Deviation 4.58	21.83 units on a scale Standard Deviation 4.52

SECONDARY outcome

Timeframe: 7 days

Participants' health beliefs were assessed using a 5-item prevention orientation scale at one week post-intervention. The scale included items, such as "Even if I do not have a family history of cancer, it is important to be checked regularly," and "It is better to detect health problems early through screening efforts than discover something later and have to treat it." Each item was rated on a 4-point Likert scale, ranging from "1=strongly disagree" to "4=strongly agree." Scores for each item were calculated by summing the item responses, with total scores ranging from 5 to 20. Higher item scores indicated stronger health beliefs related to prevention orientation. Change = (Week 1 Score - Baseline Score).

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Health Beliefs	10.19 units on a scale Standard Deviation 1.678	9.95 units on a scale Standard Deviation 1.692

SECONDARY outcome

Timeframe: 7 days

Cultural attitudes toward breast cancer screening were assessed using a 6-items cultural modesty scale. Each item was rated on a 4-point scale, ranging from "1=strongly disagree" to "4=strongly agree." Higher item scores indicated stronger belief in cultural modesty. The total score for each item was computed by summing the individual item scores, ranging from 6 to 24.

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Cultural Attitudes	11.85 units on a scale Standard Deviation 3.067	12.60 units on a scale Standard Deviation 3.509

SECONDARY outcome

Timeframe: 7 days

Number of Participants who intended to receive a mammogram in the future was assessed by a single question at both baseline and 1 week after the intervention. The single question asked whether a participant intended to receive a mammogram in the future, with response options of "0=No intention" or "1=Yes intention." The data values represent the number of participants who intended to receive a mammogram in the future with the response of "Yes intention."

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Number of Participants Who Intended to Receive a Mammogram in the Future	62 Participants	51 Participants

SECONDARY outcome

Timeframe: 7 days

Number of participants satisfied with intervention they received was assessed using a 2-point scale ranging from "1=Dissatisfied/Very dissatisfied" to "2=Satisfied/Very Satisfied" one week after the intervention. The data values represent the number of participants satisfied with intervention with response option of "2=Satisfied/Very Satisfied."

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Number of Participants Satisfied With Intervention	60 Participants	53 Participants

SECONDARY outcome

Timeframe: 7 days

Number of Participants Indicating Intervention Was Effective/Very Effective was measured one week after the intervention with the question, "Do you think that the intervention you received was effective in increasing your knowledge of breast cancer and screenings?" Participants responded on a 4-point scale item ranging from "1=very ineffectual" to "4=very effectual." The data values represent the number of participants who indicated the intervention was "3 = Effective" or "4 = Very Effective."

Outcome measures

Outcome measures
Measure	Intervention n=62 Participants Participants are randomized to interventional arm which is seven-day intervention that requires them to download mobile app to complete educational courses each day. Participants are required to complete pre- and post-tests as part of the study. The intervention encourages education on mammogram needs. Educational mobile app: 7 day educational course to educate American Indian women to receive regular mammogram.	Control n=60 Participants Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.
Number of Participants Indicating Intervention Was Effective/Very Effective	62 Participants	55 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Soonhee Roh

University of South Dakota

Phone: 6053571593

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place