Colorectal CancerNCT05345054
The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health
An observational study of Colorectal Cancer and Inflammatory Bowel Diseases, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Inflammatory Bowel Diseases, Diverticular Diseases
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2022to 12 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- -≥ 65 years old undergoing or having recently undergone colorectal surgery (<7 days) for colorectal disease
- All genders
- African American race
- Able to consent
- English-speaking
- -≥ 18 years old
Show all 14Show fewer
- All genders
- All race/ethnicities
- Able to consent English-speaking
- ≥ 18 years old undergoing or having recently undergone colorectal surgery* (<7 days) for colorectal disease**
- All genders
- All race/ethnicities
- Able to consent
- English-speaking
Who cannot join
- <65 years old
- Race other than African American
- Undergoing operation other than colorectal surgery
- Unable to consent
- Limited mental state
- Child (<18 years)
Show all 13Show fewer
- Unable to consent
- Limited mental state
- Child (<18 years)
- Undergoing operation other than colorectal surgery
- Unable to consent
- Limited mental state
- Includes colectomy/proctectomies. ** Includes colorectal cancer, inflammatory bowel disease and diverticular disease.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Russell Medical Center
Alexander City, Alabama, 35010
Whitfield Regional Medical Center
Demopolis, Alabama, 36732
Regional Medical Center of Central Alabama
Greenville, Alabama, 36037
About this study
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.
Read more
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.
- Being tested
- no intervention
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, Diverticular Diseases, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Also called no intervention planned
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | 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. Receives: Other: no intervention | |
| Phase 2 | 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. Receives: Other: no intervention | |
| Phase 3 | 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Aug 2022
- Primary completion22 Jul 2023
- Study completion12 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Chu, University of Alabama at Birmingham
- Investigators
- Daniel I Chu, MD, Principal investigator, University of Alabama in Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345054
- Sponsor's protocol ID
- 300009121
- Status last verified
- Aug 2023
- First submitted
- 2 Apr 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health
- ClinicalTrials.gov ID
- NCT05345054
- Acronym / sponsor ID
- 300009121
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 22 Jul 2023 (actual)
- Study completion
- 12 Aug 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Other: no interventionStudy 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. |
| Phase 2 | – | Other: no interventionTo 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. |
| Phase 3 | – | Other: no interventionEnrollment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (14 listed)
- -≥ 65 years old undergoing or having recently undergone colorectal surgery (<7 days) for colorectal disease
- All genders
- African American race
- Able to consent
- English-speaking
Key exclusion criteria (13 listed)
- <65 years old
- Race other than African American
- Undergoing operation other than colorectal surgery
- Unable to consent
- Limited mental state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionAlso: no intervention plannedThis 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. | Other | Phase 1, Phase 2, Phase 3 |
Primary outcome
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).
Time frame: 3 months
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.
Barriers to surgical care for older African American patients in the Deep South.
Time frame: 6 months
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.
A database linking socioecological determinants of health with nationally validated surgical outcomes.
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Chu, MD principal investigator
University of Alabama in Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Inflammatory Bowel Diseases, run by University of Alabama at Birmingham at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.