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Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial.

Carrasquillo O, McCann S, Amofah A, Pierre L, Rodriguez B, Alonzo Y, Ilangovan K, Gonzalez M, Trevil D, Byrne MM, Koru-Sengul T, Kobetz E - Trials (2014)

Bottom Line: Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices.Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care.Another recent promising approach is using human papilloma virus (HPV) self-sampling.

View Article: PubMed Central - PubMed

Affiliation: Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, USA. oc6@med.miami.edu.

ABSTRACT

Background: In the United States certain minority groups, such as racial/ethnic immigrant women, are less likely than non-Hispanic White women to be screened for cervical cancer. Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices. Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care. Another recent promising approach is using human papilloma virus (HPV) self-sampling. In this manuscript, we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women.

Design: The South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS) is conducting a three-arm randomized trial among Hispanic, Haitian, and African American women in Miami-Dade County. Community health workers (CHW) based in each of three communities are recruiting 200 women at each site (600 total). Eligibility criteria include women aged 30-65 years who have not had a Pap smear test in the last 3 years. Prior to randomization, all women undergo a standardized structured interview. Women randomized to public health outreach, Group 1, receive culturally tailored educational materials. Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities. Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling. The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6 months after enrollment.

Discussion: SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women. If successful, HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer.

Trial registration: Clinical Trials.gov # NCT02121548, registered April 21, 2014.

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SUCCESS sample size. Legend: Figure shows the sample size needed (Y axis) to achieve statistical significance with 80% and 90% power, based on varying estimates of attrition (X axis).
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Fig1: SUCCESS sample size. Legend: Figure shows the sample size needed (Y axis) to achieve statistical significance with 80% and 90% power, based on varying estimates of attrition (X axis).

Mentions: In the study, we are recruiting 600 women from three study sites. The sample size was chosen to detect effects associated with a 20 point increase in the proportion of women screened in Group 2 (CHW) versus Group 1 (outreach) and an additional 15 percentage point increase in Group 3 (HPV self-sampling) versus Group 2. In addition, as women are randomized within each site, sample size calculations were adjusted to account for clustering of patients within each community. Based on these parameters, we examined power estimates under a variety of assumptions for attrition with estimates ranging from 0% to 30%. As shown in Figure 1, with a total sample size of 600 women (200 women in community), we will have sufficient power for the main study hypotheses, under a variety of attrition rate assumptions at a 0.05 level of significance.Figure 1


Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial.

Carrasquillo O, McCann S, Amofah A, Pierre L, Rodriguez B, Alonzo Y, Ilangovan K, Gonzalez M, Trevil D, Byrne MM, Koru-Sengul T, Kobetz E - Trials (2014)

SUCCESS sample size. Legend: Figure shows the sample size needed (Y axis) to achieve statistical significance with 80% and 90% power, based on varying estimates of attrition (X axis).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4127186&req=5

Fig1: SUCCESS sample size. Legend: Figure shows the sample size needed (Y axis) to achieve statistical significance with 80% and 90% power, based on varying estimates of attrition (X axis).
Mentions: In the study, we are recruiting 600 women from three study sites. The sample size was chosen to detect effects associated with a 20 point increase in the proportion of women screened in Group 2 (CHW) versus Group 1 (outreach) and an additional 15 percentage point increase in Group 3 (HPV self-sampling) versus Group 2. In addition, as women are randomized within each site, sample size calculations were adjusted to account for clustering of patients within each community. Based on these parameters, we examined power estimates under a variety of assumptions for attrition with estimates ranging from 0% to 30%. As shown in Figure 1, with a total sample size of 600 women (200 women in community), we will have sufficient power for the main study hypotheses, under a variety of attrition rate assumptions at a 0.05 level of significance.Figure 1

Bottom Line: Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices.Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care.Another recent promising approach is using human papilloma virus (HPV) self-sampling.

View Article: PubMed Central - PubMed

Affiliation: Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, USA. oc6@med.miami.edu.

ABSTRACT

Background: In the United States certain minority groups, such as racial/ethnic immigrant women, are less likely than non-Hispanic White women to be screened for cervical cancer. Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices. Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care. Another recent promising approach is using human papilloma virus (HPV) self-sampling. In this manuscript, we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women.

Design: The South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS) is conducting a three-arm randomized trial among Hispanic, Haitian, and African American women in Miami-Dade County. Community health workers (CHW) based in each of three communities are recruiting 200 women at each site (600 total). Eligibility criteria include women aged 30-65 years who have not had a Pap smear test in the last 3 years. Prior to randomization, all women undergo a standardized structured interview. Women randomized to public health outreach, Group 1, receive culturally tailored educational materials. Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities. Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling. The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6 months after enrollment.

Discussion: SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women. If successful, HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer.

Trial registration: Clinical Trials.gov # NCT02121548, registered April 21, 2014.

Show MeSH
Related in: MedlinePlus