Trial Summary
What is the purpose of this trial?This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Asian American (Korean, Vietnamese, and Chinese) women. All women will receive an educational program and navigation assistance. Women in the intervention condition will also receive a self-sampling kit for self-collection of a cervical sample for HPV testing. The investigators will evaluate whether the inclusion of a self-sampling kit increases the proportion of Asian American women who participate in cervical cancer screening.
What safety data exists for cervical cancer screening programs for Asian American women?The studies reviewed focus on interventions to increase cervical cancer screening among underserved populations, including Asian American women. These interventions include community-based education, patient navigation, and HPV self-sampling. While the studies highlight the feasibility and effectiveness of these approaches in increasing screening rates, they do not specifically address safety data. However, the interventions are generally non-invasive and focus on education and self-sampling, which are considered safe practices.24679
Is the treatment Community-Based Education, Navigation to Screening a promising treatment for cervical cancer screening in Asian American women?Yes, the treatment is promising because it helps increase cervical cancer screening rates among Asian American women by providing education and assistance to overcome barriers to access.12589
What data supports the idea that Cervical Cancer Screening Program for Asian American Women is an effective treatment?The available research shows that the Cervical Cancer Screening Program for Asian American Women is effective in increasing screening rates. For example, a study on Korean American women found that those who participated in a community-based intervention, which included education and navigation services, had higher screening rates compared to those who did not. Another study highlighted the success of using culturally tailored interventions to promote HPV self-sampling among Asian American women, which helped overcome barriers like lack of awareness and cultural norms. These findings suggest that the program effectively addresses access barriers and increases cervical cancer screening among Asian American women.23689
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for Korean or Vietnamese American women aged 30-65 who are overdue for cervical cancer screening and have not had a recent cytology-based screen or HPV test. It's not open to those with previous cervical abnormalities, those who've had their cervix removed, anyone with compromised immunity like HIV, or if they can't consent.Inclusion Criteria
I am between 30 and 65 years old.
Exclusion Criteria
I have been diagnosed with cervical cancer or a cervical abnormality before.
I am unable to understand and give consent for treatment.
I have had my uterus and cervix removed.
Treatment Details
The study tests whether adding a self-sampling kit for HPV testing to an educational program and navigation assistance increases cervical cancer screening rates in the target group compared to just education and assistance.
2Treatment groups
Experimental Treatment
Active Control
Group I: HPV Self-SamplingExperimental Treatment3 Interventions
Previously tested evidence-based intervention (i.e. culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided). Participants will also receive a self-sampling kit.
Group II: Evidence-Based InterventionActive Control2 Interventions
Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Temple University Lewis Katz School of MedicinePhiladelphia, PA
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Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
Temple UniversityCollaborator
References
Interim assessment of a community intervention to improve breast and cervical cancer screening among Korean American women. [2019]Breast and cervical cancer screening practices are suboptimal among Korean American women. A community intervention program was launched in 1996 to improve breast and cervical cancer screening among Korean American women in Alameda County, California. After 18 months, interim program assessment revealed that mammograms improved, but Pap smears, breast self-examinations, and clinical breast examinations did not change significantly. However, results were similar for the control county probably because the program was not implemented fully. Several strategies for improving program implementation are discussed including recommendations for researchers planning community intervention projects.
Evidence-based intervention to reduce access barriers to cervical cancer screening among underserved Chinese American women. [2022]The primary objective of the present study was to evaluate the effects of a community-based pilot intervention that combined cervical cancer education with patient navigation on cervical cancer screening behaviors among Chinese American women residing in New York City.
Young Asian Americans' knowledge and perceptions of cervical cancer and the human papillomavirus. [2022]Cervical cancer is a major health disparity among Asian Americans, with cervical cancer rates of Vietnamese women being significantly higher than for the general US female population and low screening rates reported for Asian American females. Focus groups and interviews were conducted with young Vietnamese, Filipino, and Korean adults (ages 18-29) to collect information on knowledge, perceptions and sources of information regarding cervical cancer, Pap tests and the human papillomavirus. 16 Korean, 18 Vietnamese, and 18 Filipino (50% female) adults participated in the study. Many participants had never heard of HPV, cervical cancer and Pap testing. Cervical cancer screening rates were low for Korean and Vietnamese females and were influenced by moral beliefs and lack of awareness. Culturally relevant education materials that consider specific Asian ethnicity and language are needed to increase awareness of cervical cancer, Pap testing, and HPV among Asian American young adults.
Multi-site implementation of health education programs for Latinas. [2021]US Latinas are more likely to be diagnosed with late stage breast cancer and have nearly double the incidence of cervical cancer. A culturally customized educational program (Esperanza y Vida) was established in three locations to increase cancer awareness and screening. Educational programs (N = 159) were conducted, with participants randomized to either a breast and cervical (intervention) or diabetes (control) program. Variations in key factors, including gender, program location sites, language utilized, time/day of programs, and data collection method were detected, uncovering unique distributions across locations. Esperanza y Vida was successful in recruiting participants to health programs in three locations, each with a unique Latino population. Program site differences demonstrated educational and screening interventions can be implemented in multiple locations, with program variations reflecting local characteristics. These findings can be applied to outreach efforts to effectively increase participation and enhance screening practices and benefits in other regions.
Overcoming Barriers to Cervical Cancer Screening Among Asian American Women. [2021]Significant disparities in cervical cancer incidence and mortality exist among ethnic minority women, and in particular, among Asian American women. These disparities have been attributed primarily to differences in screening rates across ethnic/racial groups. Asian American women have one of the lowest rates of screening compared to other ethnic/racial groups. Yet Asian Americans, who comprise one of the fastest growing populations in the United States, have received the least attention in cancer control research. Studies suggest that various factors, including lack of knowledge, psychosocial and cultural beliefs, and access barriers, are associated with cervical cancer screening behaviors among Asian American women. Indeed, the few interventions that have been developed for Asian American women demonstrate that targeting these factors can yield significant increases in screening rates. It is important to note, however, that the effectiveness of educational interventions is often attenuated if access barriers are not adequately addressed. Hence, interventions that include key essential components, such as the use of community individuals as lay health workers, culturally-tailored and linguistically-appropriate educational materials, and navigation assistance to overcome access barriers, are more likely to be successful in enhancing screening rates. As the benefits of community-based cervical cancer prevention programs become more apparent, it will be essential to identify effective approaches for disseminating such programs more broadly. In conclusion, community-based cervical cancer screening programs have demonstrated promise in addressing existing cervical cancer disparities by increasing awareness and knowledge and promoting recommended screening behaviors. These findings will be instrumental in guiding future community-based programs to reduce cervical cancer health disparities among Asian American women.
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. [2021]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.
A Randomized Controlled Trial of a Cervical Cancer Education Intervention for Latinas Delivered Through Interactive, Multimedia Kiosks. [2021]US Latina women experience disproportionately high cervical cancer incidence and mortality rates. These health disparities are largely preventable with routine pap tests and human papillomavirus (HPV) screening. This study tested the efficacy of a cervical cancer education intervention to improve risk factor knowledge, attitudes, self-efficacy, and self-reported behavior related to cervical cancer screening among low-income Latinas who had not been screened in the past 2 years, compared to a usual care control group. Low-income Latinas who had not had a pap test in the prior 2 years were recruited from three Federally Qualified Health Centers and randomly assigned to intervention and control groups, with in-person assessment at baseline and 6-month follow-up. Women in the intervention group received a one-time low-literacy cervical cancer education program through an interactive, multimedia kiosk in either English or Spanish based on their language preference. Compared to the control group, the intervention group demonstrated greater knowledge (p
Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. [2022]Korean American women have among the lowest rates of cervical cancer screening in the United States. The authors evaluated a multicomponent intervention combining community education with navigation services to reduce access barriers and increase screening rates in this underserved population. It was hypothesized that cervical cancer screening rates would be higher among women who received the intervention program compared with those in the control program.
Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. [2023]Asian American women face disproportionate burden of cervical cancer (CC) than non-Hispanic white women in the U.S. The goal of this study was to assess the feasibility and impact of a culturally tailored intervention to promote Human papillomavirus (HPV) self-sampling test among hard-to-reach Asian American women.