RecruitingNot ApplicableNCT06416150

Reducing Urban Cervical Cancer Disparities

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


Sponsor

Fox Chase Cancer Center

Enrollment

546 participants

Start Date

Aug 28, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

Interventions

BEHAVIORALStage 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.

BEHAVIORALStage 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.

BEHAVIORALStage 2 HERS

Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.

BEHAVIORALStage 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.

BEHAVIORALStage 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.

BEHAVIORALStage 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.

BEHAVIORALStage 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.

BEHAVIORALStage 4 HERS

Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.

BEHAVIORALStage 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.


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

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NCT06416150


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