546 Participants Needed

HERS Program for Cervical Cancer

Recruiting at 2 trial locations
EK
SM
Overseen BySuzanne M Miller, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Fox Chase Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.

Research Team

SM

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.
See 2 more

Exclusion Criteria

Require follow-up but not a colposcopy
I have or had cervical cancer.
Are pregnant at the time of recruitment

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)
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
13Treatment groups
Experimental Treatment
Group I: Stage, 2, and 3 HERS + Stage 4 HERS+HCExperimental Treatment4 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 HERSExperimental Treatment3 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 HERSExperimental Treatment3 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 HERSExperimental Treatment4 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 HERSExperimental Treatment3 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 SoCExperimental Treatment2 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+HCExperimental Treatment3 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 HERSExperimental Treatment2 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 HERSExperimental Treatment4 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+HCExperimental Treatment4 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 HERSExperimental Treatment3 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+HCExperimental Treatment4 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+HCExperimental Treatment3 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.

Find a Clinic Near You

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+

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.
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.
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.
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]

References

A community capacity-enhancement approach to breast and cervical cancer screening among older women of color. [2022]
Cervical cancer prevention project for inner city black and Latina women. [2022]
Using intervention mapping as a participatory strategy: development of a cervical cancer screening intervention for Hispanic women. [2021]
Public health national approach to reducing breast and cervical cancer disparities. [2021]
Evidence-based intervention to reduce access barriers to cervical cancer screening among underserved Chinese American women. [2022]
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