Reducing Urban Cervical Cancer Disparities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorFox Chase Cancer Center
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Stage 1 SOC
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
Stage 2 HERS+HC
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralParticipants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
Stage 4 HERS+HC
BehavioralParticipants 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.
Treatment groups
546 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Group A: Stage 1 and 3 SoCExperimental treatment 2 interventions
Group B: Stage 1 and 3 SoC + Stage 4 HERSExperimental treatment 3 interventions
Group C: Stage 1 SoC + Stage 2 and 3 HERSExperimental treatment 3 interventions
Group D: Stage 1 SoC + Stage 2, 3, and 4 HERSExperimental treatment 4 interventions
Group E: Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HCExperimental treatment 4 interventions
Group F: Stage 1 and 3 HERSExperimental treatment 2 interventions
Group G: Stage 1, 3, and 4 HERSExperimental treatment 3 interventions
Group H: Stage 1 and 3 HERS + Stage 4 HERS+HCExperimental treatment 3 interventions
Group I: Stage 1, 2, and 3 HERSExperimental treatment 3 interventions
Group J: Stage 1, 2, 3, and 4 HERSExperimental treatment 4 interventions
Group K: Stage, 2, and 3 HERS + Stage 4 HERS+HCExperimental treatment 4 interventions
Group L: Stage 1 HERS + Stage 2 and 3 HERS+HCExperimental treatment 3 interventions
Group M: Stage 1 HERS + Stage 2, 3, and 4 HERS+HCExperimental treatment 4 interventions
Trial outcomes
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
Time frame
Up to 3 months post-baselineSecondary outcomes
1
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
Time frame
Up to 15 months post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fox Chase Cancer Center
Lead sponsor
Rutgers, The State University of New Jersey
Collaborator
Thomas Jefferson University
Collaborator
Temple University
Collaborator
University of South Carolina
Collaborator
Source ClinicalTrials.gov