Recruiting

Observational Study

Sponsor:

Fox Chase Cancer Center

Code:

NCT06416150

Conditions

Cervical Cancer

Papilloma Viral Infection

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Stage 1 SOC

Stage 1 HERS

Stage 2 HERS

Stage 2 HERS+HC

Stage 3 SOC

Study Details

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.

Conditions

Cervical Cancer

Papilloma Viral Infection

Study ID

NCT06416150

Start date

Aug 28, 2024

Status verified date

Oct, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

546 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Stage 2 HERS

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

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.

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.

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.

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.

Stage 4 HERS

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

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.

Primary outcome measure

  • Attendance at baseline colposcopy appointment [ Time Frame: Up to 3 months post-baseline ]

Central Contacts and Locations

Central contacts

Locations

Rutgers, The State University of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

Oct 26, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2024-10-26.