Actively Recruiting
Reducing Urban Cervical Cancer Disparities Using a Tailored MHealth Intervention to Enhance Colposcopy Attendance
Led by Fox Chase Cancer Center · Updated on 2024-10-26
546
Participants Needed
3
Research Sites
34 weeks
Total Duration
On this page
Sponsors
F
Fox Chase Cancer Center
Lead Sponsor
R
Rutgers, The State University of New Jersey
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates ways to reduce cervical cancer disparities among urban, underserved women by studying the Health Enhancement Resource System (HERS) intervention. This intervention aims to increase patient follow-up attendance after abnormal cervical test results, using text message-based counseling and supplemental telephone health coaching for women who miss appointments. The study uses a hybrid Type 1 effectiveness-implementation design and is conducted at multiple urban clinic sites serving predominantly low-income minority women. Participants scheduled for colposcopy after abnormal cervical tests are randomized to either Standard of Care or HERS text message interventions. Those who miss appointments in either group may receive additional interventions such as repeated text reminders or health coaching calls. The study includes sequential stages of intervention for baseline and 12-month follow-up colposcopy appointments, with different combinations of Standard of Care, HERS text messages, and health coaching offered based on attendance. During the study, all participants complete surveys at baseline and one week after each colposcopy appointment, alongside barriers assessments delivered via online surveys or text messages depending on the intervention group. Qualitative interviews are conducted with healthcare providers before and after implementation, and selected participants complete exit interviews after the 12-month appointment. The primary outcome measured is attendance at the baseline colposcopy, with secondary outcomes including attendance at the 12-month follow-up.
CONDITIONS
Brief Title
Reducing Urban Cervical Cancer Disparities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 90 years of age
- Referral for colposcopic evaluation at the clinic sites
- Able to communicate with ease in English
- Have a cell phone with texting ability
- Competent to give consent
You will not qualify if you...
- Pregnant at the time of recruitment
- Current evidence or history of positive invasive carcinoma of the cervix
- Require follow-up but not a colposcopy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months post-baseline
Participants receive either Standard of Care with telephone reminders and notification letters or the HERS text message-based appointment reminders and barriers counseling prior to their baseline colposcopy appointment. If participants miss their appointment, they may receive additional interventions including supplemental telephone-based health coaching.
1 baseline colposcopy appointment and up to 2 weeks of text message reminders; health coaching calls if appointment is missed
Duration - Up to 15 months post-baseline
Participants continue with the intervention assigned based on their attendance at baseline colposcopy. They receive telephone or text message reminders and barriers counseling before the 12-month follow-up colposcopy appointment. Missed appointments may trigger supplemental telephone-based health coaching.
1 follow-up colposcopy appointment and up to 2 weeks of text message reminders; health coaching calls if appointment is missed
Duration - Throughout the intervention periods as needed
Participants complete barriers assessments via text messages or online surveys as part of the intervention. Supplemental telephone-based health coaching calls are provided within 2 business days after missed appointments and are flexibly scheduled based on participant preference, lasting 15 minutes or less.
Multiple text message interactions and scheduled phone calls after missed appointments
Duration - After 12-month follow-up appointment
A subset of participants complete exit interviews after their 12-month colposcopy appointment to provide feedback on the intervention experience.
1 exit interview (may be remote or in-person)
Trial Site Locations
Total: 3 locations
1
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
S
Suzanne M Miller, PhD
E
Erin K Tagai, PhD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
13
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