Reducing Urban Cervical Cancer Disparities
1 other identifier
interventional
546
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 16, 2024
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
October 26, 2024
October 1, 2024
2.6 years
April 9, 2024
October 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Attendance at baseline colposcopy appointment
Patient attendance or non-attendance at baseline colposcopy appointment assessed via appointment attendance history in electronic medical records
Up to 3 months post-baseline
Secondary Outcomes (1)
Attendance at 12-month follow-up appointment
Up to 15 months post-baseline
Study Arms (13)
Stage 1 and 3 SoC
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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
EXPERIMENTALStart 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, 3, and 4 HERS
EXPERIMENTALStart 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 HERS + Stage 4 HERS+HC
EXPERIMENTALStart 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
EXPERIMENTALStart 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, 2, 3, and 4 HERS
EXPERIMENTALStart 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
EXPERIMENTALStart 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 and 3 HERS+HC
EXPERIMENTALStart 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
EXPERIMENTALStart 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.
Interventions
Participants will receive high Standard Care, consisting of a telephone call approximately one month before the appointment to confirm the appointment date for the baseline colposcopy appointment, followed by a notification letter including scheduled appointment date and clinic contact information should the clinic be unable to reach the patient by telephone.
Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment.
Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
Participants will receive another barriers assessment and another round of text message barriers counseling as well as health coaching (HC) after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.
Participants will receive a telephone call before their 12-month follow-up appointments to remind participants about their upcoming appointment and schedule/reschedule if needed.
Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment.
Participants will receive text message barriers counseling as well as HC after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.
Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
Participants will receive another barriers assessment and another round of text message barriers counseling as well as HC. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fox Chase Cancer Centerlead
- Rutgers, The State University of New Jerseycollaborator
- Thomas Jefferson Universitycollaborator
- Temple Universitycollaborator
- University of South Carolinacollaborator
Study Sites (3)
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne M Miller, PhD
Fox Chase Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2024
First Posted
May 16, 2024
Study Start
August 28, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
October 26, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Study data will be available after publication of the main study outcomes.
- Access Criteria
- Contact the study PI to request data or supporting information.
Data sharing is essential to increase reproducibility and transparency of research and the translation of research findings into practice, leading to improved health outcomes. Data generated from the proposed study will be shared with the research community through presentations at scientific meetings and publications in peer-reviewed journals. Further, data will be available to qualified researchers after the main findings are published in a peer-reviewed journal. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.