An observational study in Colorectal Cancer, Inflammatory Bowel Diseases and Diverticular Diseases, sponsored by University of Alabama at Birmingham. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by University of Alabama at Birmingham · Observational
Among 11 studies in Colorectal Neoplasms by University of Alabama at Birmingham — 1 open to participants now, 1 under way, none of them phase 3. Colorectal Neoplasms · University of Alabama at Birmingham.
Among the 11 studies in Colorectal Neoplasms by University of Alabama at Birmingham, this one is the only one that started in 2022, is the only observational one, and was the 9th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 120 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →1 of the 11 studies in Colorectal Neoplasms by University of Alabama at Birmingham is open now, in 1 country. Each count lists the studies.
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2022.
Median enrollment 40 across the 9 interventional studies, 120 across the 1 observational. Of the 9 that completed or were terminated, 2 (22%) have results posted.
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
1 of the studies in Colorectal Neoplasms by University of Alabama at Birmingham that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07106359University of Alabama at BirminghamInitial Testing of a Behavioral Intervention About Genetic Services for Families at Risk of Lynch Syndrome | 2027-08-31 |
Among the 11 studies in Colorectal Neoplasms by University of Alabama at Birmingham, from their registry updates:
Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population.
Objectives: While socioecological determinants of health (SEDOH) such as health literacy and socioeconomic status are known drivers of surgical disparities, an estimated 36-47% of surgical disparities remains unexplained. This gap results from limitations of current clinical datasets in capturing SEDOHs. This pilot study aims to fill this gap by (i) collecting granular SEDOH data, (ii) identifying barriers to surgical care for older African Americans, and (iii) establishing a multi-institutional clinical database through a socioecological context. These findings will help understand how SEDOHs drive surgical disparities and inform development of interventions to eliminate them in elderly African Americans.
Design and Methods: Guided by the socioecological model of health, the investigators will use mixed-methods to achieve the objectives. First, the investigators will assess the acceptability and feasibility of a 58-item SEDOH survey based on the NIH PhenX toolkit. After distributing this survey to 36 elderly (≥65 years) African American patients undergoing surgery at 3 rural, UAB-affiliated hospitals (Alex-City, Greenville, Demopolis) the investigators will conduct detailed theory guided assessments of acceptability and feasibility (SA1). Second, the investigators will conduct key informant interviews of individuals from all 5 socioecological levels at each rural hospital (n=10) to identify additional barriers and facilitators to surgical care. The investigators will purposively sample 100% of participants at the patient and caregiver level (n=12) to be elderly African Americans (SA2). Finally, the investigators will link measured SEDOH data with standardized clinical data at each hospital to establish a novel database (SA3). These findings will establish a process to measure SEDOHs across the Deep South and set the foundation for a unique database to study surgical disparities.
Significance: Development of effective multilevel interventions to eliminate surgical disparities in older African Americans is dependent on a clearer understanding of the contextual drivers of these disparities. This pilot study will accelerate understanding of these mechanism(s) through SEDOHs. It will establish a process to measure SEDOHs, identify additional barriers to surgical care not captured by NIH instruments, and build the database to study these relationships. Such findings will have the potential to impact vulnerable surgical populations in the Deep South and support the Deep South RCMAR mission to promote health and optimize health outcomes for older and rural African Americans.
Patients for participation in Phases 1, 2, and 3 will be selected from those undergoing colorectal surgery at UAB affiliated sites in Alabama (Demopolis, Greenville, Alexander City).
Additional participants for Phase 2 will come from all other socioecological levels (caregiver, provider, organizational leaders, community leaders, public policy/governmental leaders).
Inclusion Criteria for Patients for Phase 1 and 2
-≥ 65 years old undergoing or having recently undergone colorectal surgery* (\<7 days) for colorectal disease**
Exclusion Criteria for Patients for Phase 1 and 2
Inclusion Criteria for other participants in Phase 2
-≥ 18 years old
Exclusion Criteria for other participants in Phase 2
Inclusion Criteria for Phase 3
Exclusion Criteria for Phase 3
Limited mental state
Study Population and Enrollment. To ensure survey feasibility and acceptability for our target population we will purposively recruit older African American patients at each of the three participating sites. Using conservative estimates of clinical volume as well as US county level census data we estimate enrolling 3 elderly (\>65 years of age) African American participants per site per week with a target enrollment of 12 patients per site.
Other: no intervention
To gain a broad understanding of barriers to surgical access and care in the Deep South, each study site will conduct key informant interviews. Participants will be recruited from five socioecological levels: patient, caregivers/provider, organizational, community, and policy-levels. At each site, two key informant interviews will be performed at each socioecological level (2 patients, 2 caregivers, 2 providers, 2 organizational leaders, 2 community leaders, and 2 policy leaders = 12 per site). We will purposively sample 100% of the participants at the patient and caregiver level (n=12) to be African American and \>65 years old.
Other: no intervention
Enrollment Process. Eligibility criteria for this phase of study enrollment will be broadened to include all English-speaking patients \>18 years of age undergoing or having recently undergone (\<7 days) an ACS-NSQIP defined surgical procedure. At each site, eligible participants will be approached by a trained research associate pre-operatively in clinic (for elective cases) or post-operatively in the hospital (for emergency cases \<7 days). Because each enrollment site has a unique schedule, site representatives will coordinate the most efficient weekly schedule. We expect to reach our target enrollment (100 participants total, 33 at each site) in 1 year based on conservative estimates of clinical case volume. We expect to enroll at least 20% elderly participants (\>65 years of age) and between 30-50% African American participants based on county level (Greenville - Butler County, Demopolis - Marengo County, Alexander City - Tallapoosa County) census data.
Other: no intervention
This study will not involve an intervention of any sort. Participants will either take a survey or undergo an interview, and those taking the survey will have clinical data captured.
Also known as: no intervention planned
Feasibility and Acceptability of a multidimensional survey in measuring socioecological determinants of health at rural hospitals in the Black Belt of Alabama (Demopolis, Alexander City, Greenville).
Using a theory guided framework and previously published measures of acceptability and feasibility, a post survey will be administered to all participants in specific aim 1. Feasibility and acceptability scores will be calculated, with positive acceptability and feasibility being indicated by scores of 4 or greater on a likert scale. The investigators will ensure that the survey is found to be acceptable and feasible to \>70% of the target population, and will have areas for qualitative feedback and comments to adapt the survey as needed.
Time frame: 3 months
Barriers to surgical care for older African American patients in the Deep South.
To identify barriers to surgical care for older African American patients in the Deep South the investigators will conduct qualitative interviews of participants at all socioecological levels at each site. These interviews will be transcribed and coded using NVivo software, and themes from this analysis will be compared with the domains assessed in the survey used in specific aim 1 in order to ensure that all relevant domains are captured and assessed.
Time frame: 6 months
A database linking socioecological determinants of health with nationally validated surgical outcomes.
To establish a database linking socioecological determinants of health with nationally validated surgical outcomes the investigators will pair data obtained from the previously developed survey with chart abstracted clinical outcomes data. All data will be stored in a secure RedCap database, and entered only by trained abstractors.
Time frame: 12 months
Plan to share: No — Primary data acquired through the quantitative surveys and other demographics will be collected and managed using REDCap (Research Electronic Data Capture). As the host/coordinating center, UAB REDCap servers are secured through a virtualized environment behind an enterprise grade Palo Alto firewall. Only IRB-approved research team members will have access to the REDCap system through a secure and unique login. UAB REDCap is in compliance with NIST 800-53/800-171 (HIPAA) and FDA CFR21 part 11 guidelines, approved by all authorizing parties at UAB and authorized to operate (ATO) from NIH/NHLBI.
No publications or documents are linked to this record.
Ran from Aug 2022 to primary completion in Jul 2023, 11 months.
Of 528 non-industry observational studies under Colorectal Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 132. This study's 11 months is below that.
Counting every sponsor, half of 645 studies reached it within 51 months; a quarter within 27 and three quarters within 104.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →