8000 Participants Needed

Cancer Prevention Education for Breast and Cervical Cancer

(SEMM2 Trial)

LS
EA
Overseen ByEmily Adlparvar
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to increase early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and Human Papillomavirus (HPV) vaccination in underserved Latinas.

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 data supports the effectiveness of this treatment for Cancer Prevention Education for Breast and Cervical Cancer?

Research shows that education and information can help cancer patients better manage stress and anxiety, improve their understanding of the disease, and enhance their quality of life. Specifically, psychoeducation has been effective in improving adherence to treatment and reducing anxiety and depression in breast cancer patients.12345

Is the educational intervention for cancer prevention safe for humans?

The research articles reviewed focus on educational interventions for cancer prevention and do not report any safety concerns, suggesting that these interventions are generally safe for humans.678910

How is the Cancer Prevention Education treatment for breast and cervical cancer different from other treatments?

This treatment is unique because it focuses on education to prevent breast and cervical cancer, particularly targeting women in rural and resource-limited areas where access to traditional healthcare is limited. It emphasizes awareness and preventive practices rather than medical or surgical interventions.1112131415

Research Team

LS

Lara Savas, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.
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Exclusion Criteria

Current pregnancy
I have been diagnosed with cancer before or currently.

Timeline

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

Treatment Details

Interventions

  • Education
  • Navigation to clinic
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Zoom Delivered Breast and Cervical Cancer Behavioral InterventionExperimental Treatment2 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 InterventionExperimental Treatment2 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 InterventionExperimental Treatment2 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.

Find a Clinic Near You

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+

Findings from Research

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.
Information and education across the phases of cancer care.Adams, M.[2019]
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.
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]
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.
Psychoeducation for breast cancer: A systematic review and meta-analysis.Setyowibowo, H., Yudiana, W., Hunfeld, JAM., et al.[2022]

References

Information and education across the phases of cancer care. [2019]
Education and health promotion for new patients with cancer. [2022]
Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. [2023]
Psychoeducation for breast cancer: A systematic review and meta-analysis. [2022]
The impact of video-assisted education on quality of life of women with breast cancer receiving chemotherapy treatment. [2022]
Evidence-based intervention to reduce access barriers to cervical cancer screening among underserved Chinese American women. [2022]
Improving Attitudes and Beliefs of Cervical Cancer Screening Guidelines: An Evidence-Based Quality Improvement Project. [2022]
Developing a Cancer Prevention Health Education Resource: a Primer of Process and Evaluation. [2023]
Abnormal cervical screen follow-up among low-income Latinas: Project SAFe. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
The impact of a culturally tailored patient navigator program on cervical cancer prevention in Latina women. [2021]
Effectiveness of audio-visual and print media intervention on knowledge of cervical health among rural women in Southern India. [2022]
Assessment of knowledge about cervical cancer and its prevention among female students aged 17-26 years. [2022]
Targeting cervical cancer campaigns on teenage high schoolers in resource-limited economies: lessons from an intervention study of Nigerian senior secondary school girls. [2022]
Cervical Cancer Prevention Efforts in India. [2022]
Educational interventions for cervical cancer prevention: a scoping review. [2023]