Reducing Urban Cervical Cancer Disparities Using a Tailored MHealth Intervention to Enhance Colposcopy Attendance
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:
• 18 to 90 years of age (screening is still recommended for some women over 65-depending on screening and medical history and proceeds until age 90 in the study's clinic recruitment sites),
• referral for colposcopic evaluation at the clinic sites,
• able to communicate with ease in English,
• have a cell phone with texting ability, and
• competent to give consent.
Locations
United States
New Jersey
Rutgers, The State University of New Jersey
RECRUITING
New Brunswick
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Thomas Jefferson University
RECRUITING
Philadelphia
Contact Information
Primary
Suzanne M Miller, PhD
suzanne.miller@fccc.edu
215-728-4069
Backup
Erin K Tagai, PhD, MPH
erin.tagai@fccc.edu
215-728-5621
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2027-12
Participants
Target number of participants: 546
Treatments
Experimental: Stage 1 and 3 SoC
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.
Experimental: Stage 1 and 3 SoC + Stage 4 HERS
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.
Experimental: Stage 1 SoC + Stage 2 and 3 HERS
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.
Experimental: Stage 1 SoC + Stage 2, 3, and 4 HERS
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.
Experimental: Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC
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.
Experimental: Stage 1 and 3 HERS
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.
Experimental: Stage 1, 3, and 4 HERS
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.
Experimental: Stage 1 and 3 HERS + Stage 4 HERS+HC
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.
Experimental: Stage 1, 2, and 3 HERS
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.
Experimental: Stage 1, 2, 3, and 4 HERS
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.
Experimental: Stage, 2, and 3 HERS + Stage 4 HERS+HC
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.
Experimental: Stage 1 HERS + Stage 2 and 3 HERS+HC
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.
Experimental: Stage 1 HERS + Stage 2, 3, and 4 HERS+HC
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.
Related Therapeutic Areas
Sponsors
Collaborators: Rutgers, The State University of New Jersey, Temple University, Thomas Jefferson University, University of South Carolina
Leads: Fox Chase Cancer Center