HERS Program for Cervical Cancer

Recruiting at 2 trial locations

Overseen By Suzanne M Miller, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Pregnancy, Invasive carcinoma, others

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

Compensation: Varies

Number of Visits: 2

546 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Health Enhancement Resource System (HERS) in assisting women with follow-up on abnormal cervical cancer test results. HERS uses text messages and phone calls to remind and guide women who miss medical appointments. The trial includes different groups that test varying levels of support, ranging from standard care to more intensive follow-ups. Women referred for a colposcopy, who have a cell phone and can communicate in English, might be suitable candidates.

As an unphased trial, this study provides participants the chance to contribute to innovative methods that could enhance healthcare follow-up practices.

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 the Health Enhancement Resource System (HERS) intervention is safe?

Research has shown that the Health Enhancement Resource System (HERS) helps patients remember to attend follow-up appointments after receiving abnormal test results. The system sends text messages and makes phone calls to remind patients about these important medical check-ups.

Although existing studies lack specific safety data on HERS, this type of intervention is non-invasive. It does not involve surgery or medication, so it is generally considered low-risk. Text messages and phone calls are common communication methods and are usually safe.

The study phase is marked as "Not Applicable," indicating a focus on improving healthcare processes rather than testing a new drug or device. This typically suggests an emphasis on safety and minimal risk to participants. Therefore, even without direct safety data, the nature of the intervention suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HERS Program for cervical cancer because it offers a new approach to patient care by focusing on health enhancement resources alongside standard treatments. Unlike traditional methods that rely solely on medical interventions like surgery, radiation, or chemotherapy, HERS integrates patient support and education throughout the treatment process. This program aims to improve patient adherence to follow-up appointments and enhance overall health outcomes by providing a structured, staged approach that combines standard care with health-enhancing interventions. By emphasizing patient involvement and education, HERS has the potential to transform how cervical cancer is managed and improve long-term patient outcomes.

What evidence suggests that the HERS intervention could be effective for cervical cancer follow-up?

Research has shown that the Health Enhancement Resource System (HERS), which participants in this trial may receive, might help women track abnormal cervical cancer test results. Studies have found that women receiving text message reminders and counseling, components of the HERS intervention, are more likely to attend follow-up appointments. Early evidence suggests this approach can reduce missed appointments, crucial for early cancer detection and treatment. The goal is to simplify health management for women by aiding in appointment reminders and understanding next steps. This method aims to improve follow-up rates and ensure timely care. ^{1 2 4 6 7}

Who Is on the Research Team?

Suzanne Miller, MD

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Health Enhancement Resource System (HERS)

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.

How Is the Trial Designed?

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+

Rutgers, The State University of New Jersey

Collaborator

Trials

471

Recruited

81,700+

Temple University

Collaborator

Trials

321

Recruited

89,100+

University of South Carolina

Collaborator

Trials

233

Recruited

122,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10997346

Reducing Urban Cervical Cancer Disparities ... PROJECT SUMMARY/ABSTRACT Cervical cancer is one of the most preventable cancers and when diagnosed early and appropriately treated, the likelihood of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06416150

NCT06416150 | Reducing Urban Cervical Cancer Disparities This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System ...

3. withpower.com withpower.com/trial/phase-papilloma-4-2024-d239b

HERS Program for Cervical Cancer This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the efficacy of the Health Enhancement Resource System ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840399

Increasing Cervical Cancer Screening in Federally ... In this study, we estimate the number of underscreened individuals who are served by FQHCs across subgroups known to have lower CCS rates and ...

5. formative.jmir.org formative.jmir.org/2025/1/e55043

A Proposed mHealth Intervention to Address Patient Barriers ... In the Health Enhancement Resource System, patients awaiting colposcopy would receive a series of preprogrammed text messages adapted for text ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07209917

NCT07209917 | Secondary Cervical Cancer Prevention of ... In this 5-year parallel-group RCT, we will conduct a RCT to assess the efficacy of our six-month ASHA-Health HPV intervention, featuring: 1) ...

7. cancercontroltap.org cancercontroltap.org/wp-content/uploads/2025/10/FCCC-HRSA-Improving-Cervical-Cancer-Management-Toolkit.pdf

Improving Cervical Cancer Prevention, Screening, and ... This toolkit was developed to support safety-net providers as they work to improve cervical cancer prevention, screening, and management by providing practical ...