NCT06416150 · Fox Chase Cancer Center
Reducing Urban Cervical Cancer Disparities
What this study is about
This study uses a hybrid Type 1 effectiveness-implementation trial to operationalize and assess the effectiveness 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.
View original scientific description
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.
Interventions
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 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
Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
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 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 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 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.
BEHAVIORAL
Stage 4 HERS
Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.
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.
Primary outcome measures
Attendance at baseline colposcopy appointment
Time frame: Up to 3 months post-baseline
Patient attendance or non-attendance at baseline colposcopy appointment assessed via appointment attendance history in electronic medical records
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New Brunswick, New Jersey
- Philadelphia, Pennsylvania
Collaborators
Rutgers, The State University of New Jersey, Thomas Jefferson University, Temple University, University of South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 26, 2024 · Source of record for eligibility and locations