Reducing Urban Cervical Cancer Disparities

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Fox Chase Cancer Center
Study ID
NCT06416150
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Stage 1 SOC — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
  • Stage 2 HERS+HC — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
  • Stage 4 HERS+HC — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 28, 2024
Status verified
Oct 2024
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
546 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Rutgers, The State University of New JerseyNew BrunswickNew Jersey08901
Shawna Hudson, PhD
[email protected]
(848) 932-0215
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Erin Tagai, PhD, MPH
[email protected]
215-728-5621
Suzanne M Miller, Ph.D.
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Kuang-Yi Wen, PhD
[email protected]
215-503-4623

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By condition
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By specialty
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By research site
Rutgers, The State University of New Jersey· New Brunswick, NJFox Chase Cancer Center· Philadelphia, PAThomas Jefferson University· Philadelphia, PA

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