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Behavioral Intervention

HERS Program for Cervical Cancer

N/A

Recruiting

Led By Suzanne M Miller, PhD

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Display current evidence or have a history of positive invasive carcinoma of the cervix

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 months post-baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a program called the Health Enhancement Resource System (HERS) to see if it helps women follow up on abnormal test results. The program uses text messages to help women overcome barriers and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves communication rather than medication, there aren't typical drug side effects. However, participants may experience increased anxiety or stress from more frequent reminders about their health condition.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or had cervical cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months post-baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attendance at baseline colposcopy appointment

Secondary study objectives

Attendance at 12-month follow-up appointment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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

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

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.

0 / 1Eligibility criteria met