HERS Program for Cervical Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Suzanne Miller, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Fox Chase Cancer Center

Disqualifiers: Pregnancy, Invasive carcinoma, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental telephone-based Health Coaching for women who miss their appointment.

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 makes the HERS Program for Cervical Cancer treatment unique compared to other treatments?

The HERS Program for Cervical Cancer is unique because it focuses on enhancing community capacity and empowering women, particularly those from minority groups, to engage in positive health behaviors and increase cervical cancer screening rates. This approach involves community participation and support networks, which is different from traditional medical treatments that primarily focus on direct medical interventions. ^{1 2 3 4 5}

Research Team

Suzanne Miller, MD

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

This trial is for women who have had abnormal cervical cancer screening results. It's designed to help them follow up on their care using text messages and phone calls. Women must be able to receive texts and calls, but can't join if they are already following a similar program or have conditions that interfere with study participation.

Inclusion Criteria

I am between 18 and 90 years old.

Have a cell phone with texting ability

I have been referred for a specialized cervical exam.

Exclusion Criteria

Require follow-up but not a colposcopy

I have or had cervical cancer.

Are pregnant at the time of recruitment

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Intervention

Participants receive either Standard of Care or HERS intervention for the baseline colposcopy appointment

Up to 3 months

1 visit (in-person)

Follow-up Intervention

Participants continue with their last intervention assignment for the 12-month colposcopy appointment

Up to 12 months

1 visit (in-person)

Follow-up

Participants are monitored for attendance at follow-up appointments and complete surveys

Up to 15 months post-baseline

Treatment Details

Interventions

• Health Enhancement Resource System (HERS) (Behavioral Intervention)

Trial Overview The trial tests the Health Enhancement Resource System (HERS), which uses texts and health coaching calls to encourage women to follow up after an abnormal cervical screening result. The effectiveness of HERS at different stages (1-4) with or without Health Coaching (HC) compared to standard care is being studied.

Participant Groups

Group I: Stage, 2, and 3 HERS + Stage 4 HERS+HC Experimental Treatment 4 Interventions

Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention.

Group II: Stage 1, 3, and 4 HERS Experimental Treatment 3 Interventions

Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention.

Group III: Stage 1, 2, and 3 HERS Experimental Treatment 3 Interventions

Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention.

Group IV: Stage 1, 2, 3, and 4 HERS Experimental Treatment 4 Interventions

Start with Stage 1 HERS intervention; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention.

Group V: Stage 1 and 3 SoC + Stage 4 HERS Experimental Treatment 3 Interventions

Start with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention.

Group VI: Stage 1 and 3 SoC Experimental Treatment 2 Interventions

Start with Stage 1 Standard of Care; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 Standard of Care; patient attends 12-month follow-up appointment, no Stage 4 intervention.

Group VII: Stage 1 and 3 HERS + Stage 4 HERS+HC Experimental Treatment 3 Interventions

Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention.

Group VIII: Stage 1 and 3 HERS Experimental Treatment 2 Interventions

Start with Stage 1 HERS intervention; patient attends baseline colposcopy appointment, no Stage 2 intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention.

Group IX: Stage 1 SoC + Stage 2, 3, and 4 HERS Experimental Treatment 4 Interventions

Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention.

Group X: Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC Experimental Treatment 4 Interventions

Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention.

Group XI: Stage 1 SoC + Stage 2 and 3 HERS Experimental Treatment 3 Interventions

Start with Stage 1 Standard of Care; patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS intervention. Continue with Stage 3 HERS intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention.

Group XII: Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Experimental Treatment 4 Interventions

Start with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention.

Group XIII: Stage 1 HERS + Stage 2 and 3 HERS+HC Experimental Treatment 3 Interventions

Start with Stage 1 HERS intervention, patient does not attend baseline colposcopy appointment, continue with Stage 2 HERS+HC intervention. Continue with Stage 3 HERS+HC intervention; patient attends 12-month follow-up appointment, no Stage 4 intervention.

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

Rutgers, The State University of New Jersey

Collaborator

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School

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

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Hippokratis Kiaris

University of South Carolina

Chief Executive Officer since 2021

PhD in Molecular Biology

Marjorie Jenkins

University of South Carolina

Chief Medical Officer since 2023

MD

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Findings from Research

The Screening Older Minority Women project successfully used a community capacity-enhancement approach to promote breast and cervical cancer screening among older Latina and African American women, empowering them to adopt healthier behaviors.

The intervention involved recruiting members of informal support networks, highlighting the importance of community involvement in health promotion efforts for women of color.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community capacity-enhancement approach to breast and cervical cancer screening among older women of color. Bullock, K., McGraw, SA.[2022]

The project aims to educate and raise awareness about cervical cancer prevention among 500 high-risk women in Boston's inner-city communities, particularly targeting black and Latina populations who often lack access to healthcare.

The intervention focuses on increasing healthcare service utilization, ensuring follow-up after abnormal Pap test results, and fostering community healthcare provider engagement to ultimately reduce cervical cancer morbidity and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cancer prevention project for inner city black and Latina women. Rudolph, A., Kahan, V., Bordeu, M.[2022]

The AMIGAS intervention aims to increase cervical cancer screening among U.S. women of Mexican origin, addressing the higher rates of cervical cancer and lower screening rates in this population.

Developed through community engagement and intervention mapping, AMIGAS is currently being tested for its efficacy and cost-effectiveness in three locations, indicating a promising approach for improving health outcomes in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using intervention mapping as a participatory strategy: development of a cervical cancer screening intervention for Hispanic women. Byrd, TL., Wilson, KM., Smith, JL., et al.[2021]

Breast and cervical cancer significantly affect women, particularly among racial and ethnic minority groups, highlighting the need for targeted healthcare interventions.

The National Breast and Cervical Cancer Early Detection Program aims to provide comprehensive screening and treatment services to medically underserved women, which is essential for reducing cancer disparities in the U.S.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health national approach to reducing breast and cervical cancer disparities. Miller, JW., Plescia, M., Ekwueme, DU.[2021]

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]

References

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

A community capacity-enhancement approach to breast and cervical cancer screening among older women of color. [2022]

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

Cervical cancer prevention project for inner city black and Latina women. [2022]

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

Using intervention mapping as a participatory strategy: development of a cervical cancer screening intervention for Hispanic women. [2021]

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

Public health national approach to reducing breast and cervical cancer disparities. [2021]

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

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