A Community-based Intervention to Increase Early-onset Colorectal Cancer Awareness (iBeatCRC)
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|ClinicalTrials.gov Identifier: NCT04715074|
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Behavioral: Interviews Behavioral: Pilot||Not Applicable|
Colorectal cancer (CRC) is preventable when detected early. Because of effective screening, fewer Americans aged 50 and older are now being diagnosed with CRC or dying from it. Over the past 20 years, however, the number of Americans under age 50 who are diagnosed with CRC has doubled. Health experts estimate that the numbers of younger Americans with CRC will continue to increase rapidly over the next 10 years. The reasons for this increase are poorly understood. In addition, younger people are less likely to be diagnosed with CRC when the disease is still at an early stage. Also, of concern is that among men and women of all ages and all races, African-American men are the most likely to die of CRC.
Central hypotheses are: (1) Patients residing in hotspots-counties with high EOCRC incidence/mortality rates-will have significantly worse EOCRC survival juxtaposed to those in other Utah areas. (2) Rurality and county-level access to health care will contribute to an explanation of EOCRC incidence and survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Explanatory Mixed Methods Approach|
|Official Title:||iBeat CRC: A Community-based Intervention to Increase Early-onset Colorectal Cancer Awareness Using a Sequential Explanatory Mixed Methods Approach|
|Estimated Study Start Date :||October 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||June 2024|
No Intervention: Identify EOCRC Hotspots in Utah
Central hypotheses: (1) Patients residing in hotspots will have significantly worse EOCRC survival compared with those residing in other Utah areas. (2) Rurality and county-level access to healthcare will contribute to an explanation of EOCRC incidence/survival.
Experimental: Ascertain Psychosocial and Lifestyle Challenges
Drawing on factors associated with hotspots identified in Aim 1 and our team's prior research,39-44 we will develop an interview guide with five EOCRC advocate-survivors and conduct one-on-one interviews with 20 individuals first diagnosed with CRC at 18-49 years of age. Interviews will be recorded, transcribed, and analyzed using Hatch's methods previously utilized by our team.45-47
We will understand the impact psychosocial, lifestyle, and familial aspects play on an EOCRC diagnosis through 20 one-hour interviews with EOCRC patients and survivors.
Experimental: Develop and Pilot iBeat CRC
Utilizing the Behaviour Change Wheel in conjunction with results gathered from Aims 1 and 2 we will develop a theory-driven, multi-media campaign intervention to increase awareness of EOCRC, risk factors, and early detection benefit.
- EOCRC Survival Assessed by Geographic Location [ Time Frame: Year 1 ]We will use quantitative methods to link incidence and mortality data for the years 2000 to 2020 from the Utah Cancer Registry (UCR) and the Utah Population Database (UPDB) to derive county-level estimates of hotspots for early-onset colorectal cancer (EOCRC) incidence and mortality among Utahns aged 18 to 49 years and obtain county-level estimates using our previous geospatial methods.21 Counties with high EOCRC incidence and/or mortality rates will be identified as hotspots. Next, we will use UCR-UPDB linked data to determine the independent contributions of (1) geographical, (2) personal, and (3) county-level factors to EOCRC incidence and survival. We will perform hierarchical Cox regression models and implement a generalized R-square analysis to determine the variance explained by each factor.
- Impact of Psychosocial, Lifestyle, and Familial Aspects on an EOCRC Diagnosis Assessed by Interviews [ Time Frame: Year 1 ]For Objective 2 (Year 1), we will draw on factors associated with hotspots identified in Objective 1 and our team's prior research21,29-33 to develop an interview guide with six EOCRC advocate-survivors. Using the interview guide, we will conduct one-on-one interviews with 20 individuals who received a first diagnosis of CRC at age 18 to 49 years to yield a richer understanding of the impact of psychosocial, lifestyle, and familial aspects on an EOCRC diagnosis. The qualitative data obtained from these interviews will be recorded, transcribed, and analyzed using Hatch's methods as previously used by our team.34-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04715074
|Contact: Charles R. Rogers, PhD, MPH, MSemail@example.com|
|Contact: Melanie Steiner-Sherwood, PhDfirstname.lastname@example.org|