Reducing Urban Cervical Cancer Disparities
- Conditions
- Cervical CancerPapilloma Viral Infection
- Interventions
- Behavioral: Stage 1 SOCBehavioral: Stage 1 HERSBehavioral: Stage 3 HERSBehavioral: Stage 2 HERSBehavioral: Stage 3 SOCBehavioral: Stage 2 HERS+HCBehavioral: Stage 4 HERSBehavioral: Stage 4 HERS+HCBehavioral: Stage 3 HERS+HC
- Registration Number
- NCT06416150
- Lead Sponsor
- Fox Chase Cancer Center
- Brief 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.
- Detailed Description
Invasive cervical cancer is preventable with well-established screening and diagnostic tests. However, there is a large and persistent disparity gap in cervical cancer mortality rates among urban, underserved populations that continues to intensify. This gap is largely due to low follow-up after an abnormal test result leading to continued disease risk.
The study team developed an efficacious, tailored telephone counseling intervention delivered by a health coach \[Tailored Communication for Cervical Cancer Risk (TC3)\] that increased attendance at follow-up appointments for initial colposcopy among urban, underserved women. This evidence-based intervention is available for dissemination and implementation through the National Cancer Institute's Evidence-based Cancer Control Programs database. However, TC3 was developed prior to the upsurge of smartphones and texting usage and is resource-intensive, requiring dedicated staff to interview and counsel patients before their appointment, limiting its scalability and sustainability. Therefore, this study proposes use of a hybrid type 1 effectiveness-implementation study design to assess the impact of a Health Enhancement Resource System (HERS)-adapted from TC3-on attending follow-up appointments after an abnormal cervical test result.
Using a sequential, multiple assignment, randomized trial (SMART) design, a multi-site intervention study will be conducted at three high-volume, urban clinic sites in PA and NJ serving predominately low-income minority women: Fox Chase Cancer Center/Temple University Health System; Rutgers University, and Thomas Jefferson University. The study will target patients scheduled for first time or repeat colposcopy through (a) HERS text message-based barriers counseling and (b) supplemental telephone-based Health Coaching for women who miss their scheduled appointment.
Participants scheduled for a colposcopy after an abnormal cervical test will be recruited and randomized in a 1:1 ratio to receive either Standard of Care or HERS (text message intervention). Participants randomized to Standard of Care who do not attend the scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching).
For the 12-month colposcopy appointment, participants will continue with the last intervention assignment they completed for the first colposcopy appointment (i.e., Standard of Care, HERS, or HERS+HC). Again, participants randomized to Standard of Care who do not attend the 12-month scheduled colposcopy appointment will be assigned to receive HERS. Participants randomized to HERS who do not attend the 12-month scheduled colposcopy appointment will be rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC (text plus health coaching). Participants randomized to HERS+HC who do not attend the 12-month scheduled colposcopy appointment will be assigned to repeat HERS+HC.
All participants will complete surveys at baseline survey and a 1-week post-appointment survey for both colposcopy appointments. Participants will also complete a barriers assessment. Standard of Care participants will complete the assessment via online survey while HERS and HERS+HC participants will complete the barriers assessment via text message as part of the HERS text message intervention.
Qualitative interviews will be completed with providers at each site at pre-implementation and post-implementation. Additionally, a subset of participants will complete exit interviews after their 12-month colposcopy appointment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 546
- 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.
- are pregnant at the time of recruitment,
- display current evidence or have a history of positive invasive carcinoma of the cervix, or
- require follow-up but not a colposcopy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1 and 3 HERS + Stage 4 HERS+HC Stage 3 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+HC intervention. Stage 1 and 3 SoC Stage 1 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. Stage 1, 2, 3, and 4 HERS Stage 2 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. Stage, 2, and 3 HERS + Stage 4 HERS+HC Stage 2 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+HC intervention. Stage 1 and 3 HERS Stage 1 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. Stage 1, 2, and 3 HERS Stage 1 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. Stage 1 and 3 SoC + Stage 4 HERS 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. Stage 1, 3, and 4 HERS Stage 3 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. Stage 1 SoC + Stage 2 and 3 HERS Stage 1 SOC 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. Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC Stage 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Stage 1 and 3 HERS Stage 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. Stage 1 SoC + Stage 2 and 3 HERS Stage 2 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. Stage 1 SoC + Stage 2, 3, and 4 HERS Stage 1 SOC 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. Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC Stage 1 SOC 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. Stage 1 and 3 HERS + Stage 4 HERS+HC Stage 1 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+HC intervention. Stage 1 and 3 HERS + Stage 4 HERS+HC 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. Stage 1, 2, and 3 HERS Stage 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. Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC 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. Stage 1, 2, and 3 HERS Stage 2 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. Stage 1 and 3 SoC + Stage 4 HERS Stage 1 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Stage 1 SoC + Stage 2 and 3 HERS Stage 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. Stage 1, 3, and 4 HERS Stage 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. Stage 1 and 3 SoC Stage 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. Stage 1 and 3 SoC + Stage 4 HERS Stage 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Stage 1 SoC + Stage 2, 3, and 4 HERS Stage 2 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. Stage 1 SoC + Stage 2, 3, and 4 HERS Stage 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Stage 1 SoC + Stage 2, 3, and 4 HERS Stage 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. Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC Stage 2 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+HC intervention. Stage 1, 3, and 4 HERS Stage 1 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. Stage 1, 2, 3, and 4 HERS Stage 1 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. Stage 1, 2, 3, and 4 HERS Stage 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS intervention. Stage 1 HERS + Stage 2 and 3 HERS+HC Stage 1 HERS 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. Stage 1 HERS + Stage 2 and 3 HERS+HC Stage 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. Stage 1, 2, 3, and 4 HERS Stage 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. Stage, 2, and 3 HERS + Stage 4 HERS+HC Stage 1 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+HC intervention. Stage, 2, and 3 HERS + Stage 4 HERS+HC Stage 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention. Stage, 2, and 3 HERS + Stage 4 HERS+HC 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. Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Stage 1 HERS 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. Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Stage 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. Stage 1 HERS + Stage 2 and 3 HERS+HC Stage 2 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. Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Stage 2 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. Stage 1 HERS + Stage 2, 3, and 4 HERS+HC Stage 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 does not attend 12-month follow-up appointment, continue with Stage 4 HERS+HC intervention.
- Primary Outcome Measures
Name Time Method Attendance at baseline colposcopy appointment Up to 3 months post-baseline Patient attendance or non-attendance at baseline colposcopy appointment assessed via appointment attendance history in electronic medical records
- Secondary Outcome Measures
Name Time Method Attendance at 12-month follow-up appointment Up to 15 months post-baseline Patient attendance or non-attendance at 12-month follow-up appointment assessed via appointment attendance history in electronic medical records
Trial Locations
- Locations (3)
Rutgers, The State University of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States