Intervention to Promote Breast Cancer Screening Among American Indian Women

Breast Cancer Clinical Trial

Official title:

Intervention to Promote Breast Cancer Screening Among American Indian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530603
• Other study ID #: 2019-053
• Status: Completed
• Phase: N/A
• Start date: October 3, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2024
• Source: University of South Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our objectives in this project are to develop and evaluate the feasibility and effectiveness of the Mobile Web App Breast Cancer Screening (wMammogram) intervention that is culturally tailored for AI women residing in rural areas. The proposed study will be a multi-method, two-phase research project that will take place in South Dakota over a three-year period. The two phases are: (1) developing the wMammogram intervention and (2) evaluating the feasibility and efficacy of the wMammogram. Phase 1 incorporates a community-based participatory research approach and a series of focus groups with various stakeholders in American Indian (AI) communities to design a culturally informed and practically refined intervention. Phase 2 uses a randomized clinical trial (RCT) design with AI women. The wMammogram intervention will be applied throughout a seven-day period, with assessment at three intervals: baseline (face-to-face interview survey), one-week post-intervention (telephone survey), and six-month follow-up (telephone survey) and post-intervention focus group (qualitative assessment).

The wMammogram intervention will be implemented with AI women using the two-arm RCT that includes recruiting a total of 120 AI women aged 40 to 70 years and randomly assigning them to either (a) the wMammogram intervention group (n=60) to receive culturally and personally tailored multilevel and multimedia messages through a Mobile Web App along with health navigator services or (b) the control group (n=60) to receive the mailing of printed educational materials on breast cancer and relevant screening guidelines along with health navigator services.

Hypotheses: In assessing the efficacy and feasibility of the wMammogram, Investigators hypothesize that:

(H1)The wMammogram intervention participants will show a higher rate of mammograms received than will participants in the educational materials intervention.

(H2)The wMammogram intervention participants will show improvements in knowledge, attitude, and beliefs about breast cancer screening and readiness for mammography as compared to participants in the educational materials intervention.

(H3)The wMammogram intervention participants will demonstrate greater satisfaction with and acceptance of the intervention than would participants in the educational materials intervention.

Description:

Sample Size and Power Analysis: Investigators will have 120 participants in both the intervention and the control group by the six-month follow-up assessment. Considering that the possible sample attrition at the six-month follow-up is expected to be no higher than 20% (n=24), a total of 144 participants will be recruited for the baseline assessment; half will be randomly assigned to intervention (n=72) and another half assigned to control condition (n=72). Using a one-sided nonparametric Wilcoxon rank-sum test and the mixed effect ANOVA at the 0.05 level and assuming continuous scores, this sample size (60 per arm) would provide 80 percent power to reject the null hypothesis of the equality of score-changes for both groups. The key objective of the study is to acquire preliminary estimates of breast cancer screening rates after the intervention to assess if further study is warranted. As such, Investigators stress on the precision with which Investigators can estimate the breast cancer screening rate post-intervention rather than our ability to reject a specific null hypothesis. A sample size of 60 participants for each arm reflects a compromise between keeping the scope of the project within the objectives of a pilot study while ensuring a large enough sample size to estimate the breast cancer screening rate post-intervention.

Quantitative Measures (Baseline, One-Week, and Six-Month Follow-Up Assessment): Measures will be selected based on the frequency of use in cancer and health literature, psychometric properties, previous applications with AI populations, and inputs from the Community Advisory Board (CAB) and focus groups. The primary outcome criterion for efficacy is mammography receipt (or a scheduled appointment) after the intervention, which will be measured by self-report (yes or no) at six-month follow-up. The measure has been widely used and found reliable in cancer screening research. The secondary outcome criteria for efficacy include breast cancer knowledge, health beliefs, cultural attitudes, and intent to undergo screening. These measures will be administered at multiple points: baseline and one-week post-intervention. In order to assess feasibility, Investigators will measure participant satisfaction and intervention effectiveness. These measures will be administered at one week after the intervention. Confounding covariates (e.g., background, sociodemographic, and health-related information) will be collected only at the baseline assessment and used for assessing the influence of such contextual factors.

Quantitative Data Analysis: Prior to our hypotheses tests, group equivalence in terms of baseline characteristics will be examined using t-tests and chi-square tests. For Hypothesis 1, Investigators will compare the percentage of women from each condition who receive mammograms or have scheduled a mammography appointment using a chi-square test. Investigators will supplement this with logistic regression analyses to adjust for confounding covariates. For Hypothesis 2, the averages of score change (pre- to post-test) from the two conditions will be compared using the two-sample t-test, and/or the Wilcoxon rank-sum tests after assessing normality of the scores. The group difference in terms of changes in the given constructs will be tested by a mixed-effect analysis of variance (ANOVA). The mixed-effect ANOVA includes both within-subject (i.e., time: repeated measures) and between-subject factors (i.e., group: intervention versus control) and aims to examine whether there is an interaction between these two factors on the dependent variable. Bonferroni correction will be used to reduce the probability of Type 1 error for multiple comparisons. Investigators will supplement this with a regression analysis of score change in order to adjust for confounding covariates. For Hypothesis 3, averages of general satisfaction and effectiveness scores from each group will be compared using the two-sample t-test. Also, the percentage of participants from each group who endorse "yes" for the intention and recommendation items will be compared using the chi-square test. To minimize a potential non-participation bias, Investigators will closely monitor and compare the first and fourth quartiles of responses for differences in background variables and key constructs. Investigators will also carefully document the response rate over the course of this project. IBM SPSS version 25 will be used for data analyses.

Qualitative Evaluation (Six-Month Post-Intervention Focus Group): Within six months after the completion of the wMammogram intervention, a six-month post-intervention focus group (N=10) will be conducted with the wMammogram participants to solicit feedback concerning various aspects of the entire intervention, effectiveness, and recommendations for improvement. Qualitative Data Analysis for Focus Group: Focus group session will be audio-recorded, data will be transcribed verbatim, and transcripts of conversations will be entered into a qualitative management system for analyses (e.g., Nvivo). The accuracy of transcription will be independently assessed by two other collaborators who will not attend the focus groups. Data will be independently analyzed and coded by PI (Dr. Roh) and another collaborator using qualitative content analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Women who are self-identified AI women of the YST in SD

• Women who are aged 40 to 70 years

• Women who have not received a mammogram in the past two years

• Women who are willing to use their own mobile phone, iPad, tablets, and computers, or a mobile phone borrowed from the research team for the wMammogram intervention.

Exclusion Criteria:

• Women who received a mammogram in the past year

• Women who are under 40 or over 70 years of age.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Educational mobile app
7 day educational course to educate American Indian women to receive regular mammogram.

Locations

Country	Name	City	State
United States	Yankton Sioux Tribe	Lake Andes	South Dakota
United States	University of South Dakota	Vermillion	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
University of South Dakota	University of North Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mammography receipt	The receipt of a mammogram (or a scheduled appointment) will be measured by self-report (Yes, No), which will be assessed at six-month follow-up	Within 6 month
Secondary	Breast cancer knowledge	Breast cancer knowledge will be measured by the breast cancer knowledge test at baseline and one-week post-intervention. Knowledge scale consists of 28 true or false items, and the score will be computed by the number of items the participant answered correctly.	7 days
Secondary	Health beliefs	Health beliefs will be measured by Champion's health belief model (HBM) scale at baseline and one-week post-intervention. Items in the HBM scale map to three main variables that will be used in this study: perceived susceptibility (3 items), perceived benefits (5 items), and perceived barriers (11 items).	7 days
Secondary	Cultural attitudes	Cultural beliefs and attitudes toward breast cancer screening will be captured through 6 items from Tang et al.'s inventory of cultural barriers to screening among AI women and 3 items regarding fatalism developed by Taylor et al. Other attitudes to be measured include modesty (5 items), social support (6 items), and fear of discovery (1 item). The variable will be assessed at baseline and one-week post-intervention.	7 days
Secondary	Level of intention	Level of intention to obtain a mammogram will be informed by the stages of change in the trans-theoretical model, which suggests that people move through a series of progressively more committed stages toward adoption of new behavior. Adapting the model, participants will be asked to indicate their level of intention to receive a mammogram in the future on a 4-point scale (1=not within a year, 2=within a year, 3=within 3 months, and 4=within 1 month). The variable will be assessed at baseline and one-week post-intervention.	7 days
Secondary	Participant satisfaction	Participant satisfaction regarding the intervention they receive will be assessed using a 4-point scale ranging from very dissatisfied to very satisfied one week after the intervention. In addition, participants' willingness to recommend the intervention they receive will be measured (yes or no items) one week after the intervention.	7 days
Secondary	Intervention effectiveness (IE)	Intervention effectiveness will be measured by a 4-point scale item ranging from very ineffectual to very effectual. In addition, participants' perceived level of knowledge about mammography will be measured on a 3-point scale item (1=same, 2=improved, and 3=very improved) one week after the intervention.	7 days