Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560398
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Working Through Outreach Navigation and Digital Enabled Referral and Recruitment Strategies ACT WONDER²S
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Working Through Outreach Navigation and Digital Enabled Referral and Recruitment Strategies ACT WONDER²S
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT WONDER²S
Brief Summary:
The purpose of the study is to refine finalize implement and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute NCI-sponsored therapeutic clinic trials at Moffitt Cancer Center
Detailed Description:
A stratified cluster randomized design will be used to assess the impact of the Advancing Clinical Trials Working through Outreach Navigation and Digitally Enabled Referral and Recruitment Strategies ACT WONDER²S multi-level intervention on increasing referral and enrollment to NCI-sponsored therapeutic clinical trials among Black and Hispanic patients Geospatial analytics were used to identify clusters of census tracts within the Moffitt catchment area priority zones with high Black and Hispanic populations for intervention deployment Priority zones were then matched on population characteristics and randomized to receive the intervention n7 or to serve as controls n7
External target populations within the Catchment Area Priority Zone CAPZ include community residents and community physicians while internal target populations within Moffitt Cancer Center Moffitt include physicians clinical research coordinators CRCs and patients The outreach and education intervention components will be facilitated by community health educators CHEs targeting community residents Clinical Trial Education module and CHE support through the ACT WONDER²S Phone-lineEmail community physicians Continuing Medical Education sessions including implicit bias training patients at Moffitt CHE support and cancer center physiciansCRCs an implicit bias training Digitally enabled decision support tools will be developed and deployed to the CHEs a data-empowered interactive map for outreach planning Precision Engagement Tool community physicians Clinical Trial Newsletters patients at Moffitt a clinical trial decision aid CHOICES DA and cancer center physiciansCRCs a recruitment dashboard to monitor clinical trial accrual rates a clinical trial portfolio profiler and a tool to assess the impact of clinical trial inclusionexclusion criteria on eligibility across patient populations defined by age race and ethnicity Eligibility Criteria Calculator In addition an online portal called the Trial Connect Portal will be developed to connect community-based referring physicians to information about MCC trials and to facilitate their communication with cancer center physicians and CRCs The primary outcome enrollment to clinical trials will be measured by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment trials who are Black or Hispanic between intervention priority zones and the control priority zones The secondary outcome referral to Moffitt will be measured by comparing the percentage of patients referred to Moffitt who are Black or Hispanic between the intervention priority zones and the control priority zones
External target populations within the Catchment Area Priority Zone CAPZ include community residents and community physicians while internal target populations within Moffitt Cancer Center Moffitt include physicians clinical research coordinators CRCs and patients The outreach and education intervention components will be facilitated by community health educators CHEs targeting community residents Clinical Trial Education module and CHE support through the ACT WONDER²S Phone-lineEmail community physicians Continuing Medical Education sessions including implicit bias training patients at Moffitt CHE support and cancer center physiciansCRCs an implicit bias training Digitally enabled decision support tools will be developed and deployed to the CHEs a data-empowered interactive map for outreach planning Precision Engagement Tool community physicians Clinical Trial Newsletters patients at Moffitt a clinical trial decision aid CHOICES DA and cancer center physiciansCRCs a recruitment dashboard to monitor clinical trial accrual rates a clinical trial portfolio profiler and a tool to assess the impact of clinical trial inclusionexclusion criteria on eligibility across patient populations defined by age race and ethnicity Eligibility Criteria Calculator In addition an online portal called the Trial Connect Portal will be developed to connect community-based referring physicians to information about MCC trials and to facilitate their communication with cancer center physicians and CRCs The primary outcome enrollment to clinical trials will be measured by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment trials who are Black or Hispanic between intervention priority zones and the control priority zones The secondary outcome referral to Moffitt will be measured by comparing the percentage of patients referred to Moffitt who are Black or Hispanic between the intervention priority zones and the control priority zones
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None