Reducing Urban Cervical Cancer Disparities

Reducing Urban Cervical Cancer Disparities Using a Tailored mHealth Intervention to Enhance Colposcopy Attendance

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer; Papilloma Viral Infection
• Intervention / Treatment: Behavioral: Stage 1 SOC; Behavioral: Stage 3 SOC; Behavioral: Stage 4 HERS; Behavioral: Stage 2 HERS; Behavioral: Stage 3 HERS; Behavioral: Stage 4 HERS+HC; Behavioral: Stage 1 HERS; Behavioral: Stage 2 HERS+HC; Behavioral: Stage 3 HERS+HC

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.

• Study Type: Interventional
• Enrollment (Estimated): 546
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzanne M Miller, PhD; Phone Number: 215-728-4069; Email: suzanne.miller@fccc.edu
• Study Contact Backup: Name: Erin K Tagai, PhD, MPH; Phone Number: 215-728-5621; Email: erin.tagai@fccc.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers, the State University of New Jersey
      • Contact: Shawna Hudson, PhD; Phone Number: 848-932-0215; Email: hudsonsh@rutgers.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Stage 1 SOC; 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.; Behavioral: Stage 3 SOC; 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.
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.	Behavioral: Stage 1 SOC; 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.; Behavioral: Stage 3 SOC; 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.; Behavioral: Stage 4 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
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.	Behavioral: Stage 1 SOC; 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.; Behavioral: Stage 2 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.
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.	Behavioral: Stage 1 SOC; 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.; Behavioral: Stage 4 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 2 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.
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.	Behavioral: Stage 1 SOC; 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.; Behavioral: Stage 2 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 4 HERS+HC; 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.
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.	Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 1 HERS; 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.
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.	Behavioral: Stage 4 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 1 HERS; 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.
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.	Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 4 HERS+HC; 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.; Behavioral: Stage 1 HERS; 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.
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.	Behavioral: Stage 2 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 1 HERS; 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.
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.	Behavioral: Stage 4 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 2 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 1 HERS; 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.
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.	Behavioral: Stage 2 HERS; Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.; Behavioral: Stage 3 HERS; 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.; Behavioral: Stage 4 HERS+HC; 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.; Behavioral: Stage 1 HERS; 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.
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.	Behavioral: Stage 1 HERS; 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.; Behavioral: Stage 2 HERS+HC; 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.; Behavioral: Stage 3 HERS+HC; 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.
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.	Behavioral: Stage 4 HERS+HC; 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.; Behavioral: Stage 1 HERS; 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.; Behavioral: Stage 2 HERS+HC; 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.; Behavioral: Stage 3 HERS+HC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance at 12-month follow-up appointment	Patient attendance or non-attendance at 12-month follow-up appointment assessed via appointment attendance history in electronic medical records	Up to 15 months post-baseline

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: University of South Carolina; Temple University; Thomas Jefferson University; Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Suzanne M Miller, PhD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Virus Diseases; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: 23-1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Study data will be available after publication of the main study outcomes.
• IPD Sharing Access Criteria: Contact the study PI to request data or supporting information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No