Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-09
Brief Title:
Reducing Urban Cervical Cancer Disparities
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Reducing Urban Cervical Cancer Disparities Using a Tailored mHealth Intervention to Enhance Colposcopy Attendance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Institutes 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 CenterTemple 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 11 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 HERSHC 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 ie Standard of Care HERS or HERSHC 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 HERSHC text plus health coaching Participants randomized to HERSHC who do not attend the 12-month scheduled colposcopy appointment will be assigned to repeat HERSHC
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 HERSHC 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
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 Institutes 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 CenterTemple 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 11 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 HERSHC 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 ie Standard of Care HERS or HERSHC 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 HERSHC text plus health coaching Participants randomized to HERSHC who do not attend the 12-month scheduled colposcopy appointment will be assigned to repeat HERSHC
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 HERSHC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None