Cancer Prevention Education for Breast and Cervical Cancer

(SEMM2 Trial)

Overseen By Emily Adlparvar

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pregnancy, Cancer diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve early detection and prevention of breast and cervical cancer among underserved Latinas through education and guidance. It provides information and assistance on obtaining breast and cervical cancer screenings and the HPV vaccine. Participants receive support in various ways: in-person, over the phone, or via Zoom. Women living in certain Texas areas who haven't had recent cancer screenings or the HPV vaccine may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational intervention and navigation to clinic are safe?

Research shows that community health workers (CHWs) effectively and safely teach cancer prevention. Studies have found that CHWs increase breast and cervical cancer screenings without causing harm. These efforts involve educating people about cancer and their screening options, whether in person, over the phone, or through Zoom.

Evidence strongly supports the safety of these methods. One review found that using CHWs to promote cancer screenings does not cause negative effects. Another study showed that education and outreach by CHWs improve health understanding without safety issues. These findings suggest that the education and guidance provided in this trial are safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cancer prevention education methods because they focus on making healthcare more accessible and personalized. Unlike traditional screenings and check-ups, these interventions are delivered by community health workers who provide tailored education and referrals to affordable services. What's unique is the flexibility in delivery: participants can receive this education in person, over the phone, or via Zoom, allowing for a more convenient and adaptable approach. By addressing barriers and connecting individuals to safety-net clinics, these methods aim to improve early detection and prevention of breast and cervical cancer in underserved communities.

What evidence suggests that this trial's educational interventions could be effective for breast and cervical cancer prevention?

This trial will compare different methods of delivering educational interventions for breast and cervical cancer prevention. Studies have shown that educational programs effectively encourage people to get screened and take preventive steps for these cancers. Participants may receive education in person, which has been linked to increased knowledge and motivation for screening, aiding early detection and reducing cases. Another group will receive education over the phone; research shows this method can improve screening participation by about 20% among those less likely to take part. Although less evidence exists for education delivered via Zoom, the trial will explore its potential to increase awareness and willingness to make health changes. Overall, these educational approaches seem promising in helping people take preventive actions against cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Lara Savas, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for Latina women in certain Texas counties who are over 40 with no mammogram in the last 2 years, aged 21-65 with no Pap test in the past 3 years, or aged 18-26 (up to age 45 if recommended) needing HPV vaccination. Pregnant women or those with a current/past cancer diagnosis cannot join.

Inclusion Criteria

You primarily reside in one of the Gulf Coast/Lower Rio Grande Valley counties or other Texas-based locales.

I am a woman over 40 and haven't had a mammogram in the last 2 years.

I am a woman aged 21-65 and haven't had a Pap test in over 3 years.

Exclusion Criteria

Current pregnancy

I have been diagnosed with cancer before or currently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Navigation

Community health workers deliver behavioral education and referrals to low-cost services, followed by health coach navigators addressing barriers and connecting participants to safety-net clinics.

9 months

Multiple sessions (in-person, telephone, or Zoom)

Follow-up

Participants are monitored for completion of Pap test screening, HPV vaccination, and mammogram screening through follow-up surveys.

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Education
• Navigation to clinic

Trial Overview The study aims to improve early detection and prevention of breast and cervical cancer among underserved Latinas through educational programs and helping them navigate healthcare services to get screened for cancer and receive HPV vaccinations.

How Is the Trial Designed?

Group I: Zoom Delivered Breast and Cervical Cancer Behavioral Intervention Experimental Treatment 2 Interventions

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by Zoom to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Group II: Telephone Delivered Breast and Cervical Cancer Behavioral Intervention Experimental Treatment 2 Interventions

Community health worker delivered behavioral education and referrals to low-cost services. Delivered by telephone to individual participants. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Group III: In-Person Delivered Breast and Cervical Cancer Behavioral Intervention Experimental Treatment 2 Interventions

Community health worker delivered behavioral education and referrals to low-cost services. Delivered in person to participants in community and clinic settings. Participants are followed up by health coach navigators to address barriers and connect to safety-net clinics.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Published Research Related to This Trial

Psychoeducation significantly reduced anxiety levels and improved the quality of life (QoL) for women with breast cancer, based on a meta-analysis of 27 randomized controlled trials involving 7742 participants.

However, psychoeducation did not show a significant impact on adherence to diagnostic procedures, treatment, depression, or breast cancer knowledge, indicating its benefits may be more focused on emotional support rather than treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation for breast cancer: A systematic review and meta-analysis. Setyowibowo, H., Yudiana, W., Hunfeld, JAM., et al.[2022]

A new ten-page women's health and cancer prevention learning guide was developed specifically for women in the criminal justice system, covering important topics like cervical cancer, breast cancer, STIs, and unintended pregnancy prevention.

Feedback from a sample of 33 women indicated a strong interest in more information about birth control side effects and STI testing and treatment, while they expressed satisfaction with the cancer prevention content, highlighting the guide's relevance and potential impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Cancer Prevention Health Education Resource: a Primer of Process and Evaluation. Kelly, PJ., Driscoll, D., Lipnicky, A., et al.[2023]

Cancer patient education should go beyond just providing information; it must also include teaching coping skills and new strategies to manage the disease, which can lead to better treatment adherence and reduced anxiety.

Focusing on the different phases of cancer care can help identify essential educational content, and ongoing research is crucial for developing effective teaching methods and evaluating their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and education across the phases of cancer care. Adams, M.[2019]

Video-assisted education significantly improved the quality of life for women undergoing their first chemotherapy treatment for breast cancer, as evidenced by reduced breast and arm symptoms from the first to the fourth cycle of chemotherapy.

In contrast to the control group, which experienced worsening symptoms, the education group showed better management of nausea, vomiting, and loss of appetite, highlighting the importance of educational interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of video-assisted education on quality of life of women with breast cancer receiving chemotherapy treatment. Ünal Toprak, F., Uysal, N., Kutlutürkan, S., et al.[2022]

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]

This systematic review aims to evaluate the outcomes of patient education for adults taking oral anticancer agents, addressing a gap in the literature regarding safety and efficacy concerns raised by patients.

The review will analyze various factors such as content, methodology, and healthcare professionals involved, which could lead to improved safety and patient satisfaction in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. Fonda, F., Cedrone, S., Sartor, I., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10994759/

A Systematic Review of the Effectiveness of Health Education ... Our findings suggest that educational interventions are effective in encouraging cervical cancer screening and prevention behavior.

2. stacks.cdc.gov stacks.cdc.gov/view/cdc/164174/cdc_164174_DS11.pdf

Interventions Engaging Community Health Workers — ... Used education materials to describe cervical cancer, related risk factors, benefits of screening, and screening process. Materials composed of video showing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4012006/

Evaluating Outcomes of Community-Based Cancer ... This paper presents an analysis of research published in the Journal of Cancer Education from 2000 through 2010, in which the impact of cancer education ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06869759?term=AREA%5BBasicSearch%5D(cluster%20randomized%20trials)&rank=3

Effectiveness of Community Health Workers in Breast ... Expected outcomes include improved breast cancer knowledge, perception, and screening intention, leading to early detection and reduced prevalence. However, ...

5. ascopubs.org ascopubs.org/doi/10.1200/jgo.18.70400

Effectiveness of a Community Health Worker-Delivered ... Conclusion: This RCT intervention trial provides evidence that the adapted intervention effectively increased breast and cervical cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10033345/

CHWs to Increase Cancer Screening: 3 Community Guide ... This systematic review is a comprehensive assessment of interventions engaging CHWs to increase screening for breast, cervical, and colorectal cancer across ...

7. cdc.gov cdc.gov/chronic-disease/php/community-health-worker-resources/index.html

Resources for Community Health Workers | Chronic Disease The Community Preventive Services Task Force recommends the use of one-on-one education to increase screening for breast cancer. Interventions ...

8. thecommunityguide.org thecommunityguide.org/findings/cancer-screening-interventions-engaging-community-health-workers-cervical-cancer.html

Cervical Cancer: Community Health Workers Task Force recommends engaging community health workers to increase screening cervical cancer by Pap smear. Read effectiveness and economic evidence.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06365450

Breast and Cervical Cancer Education Program (OCEAP) This study involves an educational intervention delivered virtually and in person, depending on the participants' preference. Detailed ...

10. odphp.health.gov odphp.health.gov/healthypeople/tools-action/browse-evidence-based-resources/cancer-screening-interventions-engaging-community-health-workers-breast-cancer

Cancer Screening: Interventions Engaging Community Health ... The Community Preventive Services Task Force (CPSTF) recommends interventions that engage community health workers to increase screening mammograms.