Cervical Cancer Screening Program for Asian American Women

Recruiting in Palo Alto (17 mi)

Overseen by Carolyn Y Fang, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Fox Chase Cancer Center

No Placebo Group

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{1 3 5 8 9}

Research Team

Carolyn Y Fang, PhD

Principal Investigator

Fox Chase Cancer Center

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 haven't had a cervical cancer screening in the recommended time frame.

Only women who are of Asian race and identify themselves as Korean or Vietnamese are eligible to participate.

I am between 30 and 65 years old.

Exclusion Criteria

Have a compromised immune system (e.g., known HIV)

I have been diagnosed with cervical cancer or a cervical abnormality before.

I am unable to understand and give consent for treatment.

Treatment Details

Interventions

• Community-Based Education (Behavioral Intervention)
• HPV Self-Sampling (Behavioral Intervention)
• Navigation to Screening (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: HPV Self-Sampling Experimental Treatment 3 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 Intervention Active Control 2 Interventions

Culturally appropriate educational intervention focused on cervical cancer screening, with navigation assistance provided.

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Dr. James Helstrom

Fox Chase Cancer Center

Chief Medical Officer since 2014

MD from University of Colorado School of Medicine, MBA from Washington University in St. Louis

Dr. Robert Uzzo

Fox Chase Cancer Center

Chief Executive Officer since 2022

MD from Cleveland Clinic, MBA

Temple University

Collaborator

Trials

321

Recruited

89,100+

Dr. Kumar Budur

Temple University

Chief Medical Officer

MD, MS

Dr. Jeffrey M. Dayno

Temple University

Chief Executive Officer

MD from Temple University School of Medicine

Findings from Research

A community-based intervention combining cervical cancer education and patient navigation significantly increased screening rates among Chinese American women, with 70% of participants in the intervention group getting screened compared to only 11.1% in the control group over a 12-month period.

Factors such as older age and greater perceived severity of cervical cancer were associated with higher screening rates, while poorer English fluency and lack of health insurance were barriers to obtaining screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based intervention to reduce access barriers to cervical cancer screening among underserved Chinese American women. Wang, X., Fang, C., Tan, Y., et al.[2022]

A study involving 52 young adults (ages 18-29) from Korean, Vietnamese, and Filipino backgrounds revealed that many participants were unaware of cervical cancer, HPV, and Pap tests, highlighting a significant knowledge gap.

Low cervical cancer screening rates among Korean and Vietnamese females were linked to moral beliefs and lack of awareness, indicating a need for culturally tailored educational materials to improve understanding and increase screening rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Young Asian Americans' knowledge and perceptions of cervical cancer and the human papillomavirus. Gor, BJ., Chilton, JA., Camingue, PT., et al.[2022]

A multicomponent intervention that included culturally relevant cancer education and navigation services significantly increased cervical cancer screening rates among Korean American women, with an odds ratio of 25.9 compared to a control group.

The study involved 705 women recruited from 22 churches, and 12 months after the intervention, data from 588 participants showed that the program effectively addressed access barriers to screening in this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. Fang, CY., Ma, GX., Handorf, EA., et al.[2022]

The SUCCESS trial is testing innovative approaches to increase cervical cancer screening among underserved minority women, including HPV self-sampling and patient navigation, with a total of 600 participants aged 30-65 who have not been screened in the last 3 years.

If effective, HPV self-sampling could significantly improve access to cervical cancer screening in these communities, addressing barriers related to health insurance, cost, and cultural norms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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., et al.[2021]

A culturally tailored intervention significantly increased HPV-related knowledge, social support, self-efficacy, and comfort with self-sampling tests among 156 low-income Asian American women, demonstrating its effectiveness in this population.

This study is the first to promote HPV self-sampling tests specifically among Asian American women, highlighting the importance of community-based approaches in addressing health disparities in cervical cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. Ma, GX., Zhu, L., Zhai, S., et al.[2023]

The culturally customized educational program 'Esperanza y Vida' successfully recruited 159 participants across three different locations, aiming to increase cancer awareness and screening among US Latinas, who face higher rates of late-stage breast and cervical cancers.

The program demonstrated that educational and screening interventions can be tailored to fit the unique characteristics of different Latino populations, suggesting that similar outreach efforts could effectively enhance cancer screening practices in various regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-site implementation of health education programs for Latinas. Sudarsan, NR., Jandorf, L., Erwin, DO.[2021]

A one-time interactive, multimedia education program significantly improved cervical cancer knowledge and attitudes among low-income Latina women who had not been screened in the past 2 years, compared to a control group.

Despite the positive changes in knowledge and attitudes, the intervention did not lead to a significant increase in actual cervical cancer screening behavior, as both groups had similar rates of obtaining or making appointments for pap tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Cervical Cancer Education Intervention for Latinas Delivered Through Interactive, Multimedia Kiosks. Valdez, A., Napoles, AM., Stewart, SL., et al.[2021]

A community intervention program aimed at increasing breast and cervical cancer screening among Korean American women led to a significant improvement in mammogram rates after 18 months, but did not significantly affect Pap smears, breast self-examinations, or clinical breast examinations.

The lack of significant changes in some screening practices was likely due to incomplete implementation of the program, highlighting the importance of effective execution in community health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim assessment of a community intervention to improve breast and cervical cancer screening among Korean American women. Wismer, BA., Moskowitz, JM., Min, K., et al.[2019]

Cervical cancer screening rates among Asian American women are among the lowest compared to other ethnic/racial groups, contributing to significant disparities in cervical cancer incidence and mortality.

Community-based interventions that address knowledge gaps, cultural beliefs, and access barriers, such as using lay health workers and providing tailored educational materials, have shown promise in significantly increasing screening rates among Asian American women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming Barriers to Cervical Cancer Screening Among Asian American Women. Fang, CY., Ma, GX., Tan, Y.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evidence-based intervention to reduce access barriers to cervical cancer screening among underserved Chinese American women. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Young Asian Americans' knowledge and perceptions of cervical cancer and the human papillomavirus. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Empowering Low-Income Asian American Women to Conduct Human Papillomavirus Self-Sampling Test: A Community-Engaged and Culturally Tailored Intervention. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Multi-site implementation of health education programs for Latinas. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Cervical Cancer Education Intervention for Latinas Delivered Through Interactive, Multimedia Kiosks. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Interim assessment of a community intervention to improve breast and cervical cancer screening among Korean American women. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Overcoming Barriers to Cervical Cancer Screening Among Asian American Women. [2021]