Trial Title:
Reducing Urban Cervical Cancer Disparities
NCT ID:
NCT06416150
Condition:
Cervical Cancer
Papilloma Viral Infection
Conditions: Official terms:
Virus Diseases
Papillomavirus Infections
Uterine Cervical Neoplasms
Papilloma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Stage 1 SOC
Description:
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.
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage 1 SoC + Stage 2, 3, and 4 HERS
Arm group label:
Stage 1 and 3 SoC
Arm group label:
Stage 1 and 3 SoC + Stage 4 HERS
Intervention type:
Behavioral
Intervention name:
Stage 1 HERS
Description:
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.
Arm group label:
Stage 1 HERS + Stage 2 and 3 HERS+HC
Arm group label:
Stage 1 HERS + Stage 2, 3, and 4 HERS+HC
Arm group label:
Stage 1 and 3 HERS
Arm group label:
Stage 1 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage 1, 2, 3, and 4 HERS
Arm group label:
Stage 1, 2, and 3 HERS
Arm group label:
Stage 1, 3, and 4 HERS
Arm group label:
Stage, 2, and 3 HERS + Stage 4 HERS+HC
Intervention type:
Behavioral
Intervention name:
Stage 2 HERS
Description:
Participants will receive another barriers assessment and another round of text message
appointment reminders and barriers messages.
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage 1 SoC + Stage 2, 3, and 4 HERS
Arm group label:
Stage 1, 2, 3, and 4 HERS
Arm group label:
Stage 1, 2, and 3 HERS
Arm group label:
Stage, 2, and 3 HERS + Stage 4 HERS+HC
Intervention type:
Behavioral
Intervention name:
Stage 2 HERS+HC
Description:
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.
Arm group label:
Stage 1 HERS + Stage 2 and 3 HERS+HC
Arm group label:
Stage 1 HERS + Stage 2, 3, and 4 HERS+HC
Intervention type:
Behavioral
Intervention name:
Stage 3 SOC
Description:
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.
Arm group label:
Stage 1 and 3 SoC
Arm group label:
Stage 1 and 3 SoC + Stage 4 HERS
Intervention type:
Behavioral
Intervention name:
Stage 3 HERS
Description:
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.
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage 1 SoC + Stage 2, 3, and 4 HERS
Arm group label:
Stage 1 and 3 HERS
Arm group label:
Stage 1 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage 1, 2, 3, and 4 HERS
Arm group label:
Stage 1, 2, and 3 HERS
Arm group label:
Stage 1, 3, and 4 HERS
Arm group label:
Stage, 2, and 3 HERS + Stage 4 HERS+HC
Intervention type:
Behavioral
Intervention name:
Stage 3 HERS+HC
Description:
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.
Arm group label:
Stage 1 HERS + Stage 2 and 3 HERS+HC
Arm group label:
Stage 1 HERS + Stage 2, 3, and 4 HERS+HC
Intervention type:
Behavioral
Intervention name:
Stage 4 HERS
Description:
Participants will receive another barriers assessment and another round of text message
appointment reminders and barriers messages.
Arm group label:
Stage 1 SoC + Stage 2, 3, and 4 HERS
Arm group label:
Stage 1 and 3 SoC + Stage 4 HERS
Arm group label:
Stage 1, 2, 3, and 4 HERS
Arm group label:
Stage 1, 3, and 4 HERS
Intervention type:
Behavioral
Intervention name:
Stage 4 HERS+HC
Description:
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.
Arm group label:
Stage 1 HERS + Stage 2, 3, and 4 HERS+HC
Arm group label:
Stage 1 SoC + Stage 2 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage 1 and 3 HERS + Stage 4 HERS+HC
Arm group label:
Stage, 2, and 3 HERS + Stage 4 HERS+HC
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.
Detailed description:
Invasive cervical cancer is preventable with well-established screening and diagnostic
tests. However, there is a large and persistent disparity gap in cervical cancer
mortality rates among urban, underserved populations that continues to intensify. This
gap is largely due to low follow-up after an abnormal test result leading to continued
disease risk.
The study team developed an efficacious, tailored telephone counseling intervention
delivered by a health coach [Tailored Communication for Cervical Cancer Risk (TC3)] that
increased attendance at follow-up appointments for initial colposcopy among urban,
underserved women. This evidence-based intervention is available for dissemination and
implementation through the National Cancer Institute's Evidence-based Cancer Control
Programs database. However, TC3 was developed prior to the upsurge of smartphones and
texting usage and is resource-intensive, requiring dedicated staff to interview and
counsel patients before their appointment, limiting its scalability and sustainability.
Therefore, this study proposes use of a hybrid type 1 effectiveness-implementation study
design to assess the impact of a Health Enhancement Resource System (HERS)-adapted from
TC3-on attending follow-up appointments after an abnormal cervical test result.
Using a sequential, multiple assignment, randomized trial (SMART) design, a multi-site
intervention study will be conducted at three high-volume, urban clinic sites in PA and
NJ serving predominately low-income minority women: Fox Chase Cancer Center/Temple
University Health System; Rutgers University, and Thomas Jefferson University. The study
will target patients scheduled for first time or repeat colposcopy through (a) HERS text
message-based barriers counseling and (b) supplemental telephone-based Health Coaching
for women who miss their scheduled appointment.
Participants scheduled for a colposcopy after an abnormal cervical test will be recruited
and randomized in a 1:1 ratio to receive either Standard of Care or HERS (text message
intervention). Participants randomized to Standard of Care who do not attend the
scheduled colposcopy appointment will be assigned to receive HERS. Participants
randomized to HERS who do not attend the scheduled colposcopy appointment will be
rerandomized to receive either HERS (repeating the text message intervention) or HERS+HC
(text plus health coaching).
For the 12-month colposcopy appointment, participants will continue with the last
intervention assignment they completed for the first colposcopy appointment (i.e.,
Standard of Care, HERS, or HERS+HC). Again, participants randomized to Standard of Care
who do not attend the 12-month scheduled colposcopy appointment will be assigned to
receive HERS. Participants randomized to HERS who do not attend the 12-month scheduled
colposcopy appointment will be rerandomized to receive either HERS (repeating the text
message intervention) or HERS+HC (text plus health coaching). Participants randomized to
HERS+HC who do not attend the 12-month scheduled colposcopy appointment will be assigned
to repeat HERS+HC.
All participants will complete surveys at baseline survey and a 1-week post-appointment
survey for both colposcopy appointments. Participants will also complete a barriers
assessment. Standard of Care participants will complete the assessment via online survey
while HERS and HERS+HC participants will complete the barriers assessment via text
message as part of the HERS text message intervention.
Qualitative interviews will be completed with providers at each site at
pre-implementation and post-implementation. Additionally, a subset of participants will
complete exit interviews after their 12-month colposcopy appointment.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Rutgers, The State University of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shawna Hudson, PhD
Phone:
(848) 932-0215
Email:
hudsonsh@rutgers.edu
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kuang-Yi Wen, PhD
Phone:
215-503-4623
Email:
kuang-yi.wen@jefferson.edu
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Tagai, PhD, MPH
Phone:
215-728-5621
Email:
erin.tagai@fccc.edu
Contact backup:
Last name:
Suzanne M Miller, Ph.D.
Start date:
August 28, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Collaborator:
Agency:
Thomas Jefferson University
Agency class:
Other
Collaborator:
Agency:
Temple University
Agency class:
Other
Collaborator:
Agency:
University of South Carolina
Agency class:
Other
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06416150
