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Trial record 3 of 4 for:    iBEAT

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
Sponsor:
Information provided by (Responsible Party):
Charles R. Rogers, PhD, MPH, MS, University of Utah

Brief Summary:
Dr. Rogers' long-term goal is to better understand the etiology of an early-onset colorectal (CRC) diagnosis and to improve long-term survivorship and quality of life for early-onset CRC (EOCRC) survivors globally by studying the burdens accompanying this condition. The goal of this study is to better understand the reasons why people under age 50 in Utah are being diagnosed with CRC. As a first step, the researchers plan to identify the specific places in Utah where diagnoses of CRC among younger people are increasing the most. Next, they plan to conduct 1-hour recorded Zoom interviews over phone and/or video with 20 people who live in these places and were diagnosed with CRC when they were under age 50. Thirdly, the researchers plan to create and test a program that will raise Utahns' awareness of the increasing risk of CRC among residents of the state who are aged under 50. This study is unique as CRC survivors are key to helping drive the study forward.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Interviews Behavioral: Pilot Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Explanatory Mixed Methods Approach
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Identify EOCRC Hotspots in Utah
  1. Linking incidence and mortality data (years 2000-2020) from the Utah Cancer Registry (UCR) and the Utah Population Database (UPDB), we will derive county-level estimates of hotspots for EOCRC incidence and mortality among Utahns aged 18-49; we will obtain county-level estimates using our geospatial methods.39 Counties with high EOCRC incidence and/or mortality rates will be identified as hotspots.
  2. Using UCR-UPBD linked data, we will determine independent contributions of (1) geographical, (2) personal, and (3) county-level factors on EOCRC incidence/survival. We will perform hierarchical Cox regression models and implement a generalized R-square analysis to determine the variance explained by each factor.

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
Behavioral: Interviews
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
  1. Intervention development will be informed by (1) integrating Aims 1 and 2 findings, (2) Community Action Board [CAB] input, and (3) the Behaviour Change Wheel,48 a step-by-step intervention development approach that identifies and addresses barriers using theory and evidence-based methods.
  2. The intervention pilot may be based on a multicomponent media campaign, as endorsed by the Community Preventive Services Taskforce for promoting CRC screening among individuals ≥ age 50.49,50 iBeat CRC may entail both outdoor mass media and online social media. iBeat CRC will target Utah hotspots and non-hotspots for comparison, with pre-post-assessment among 17 individuals in each group.
Behavioral: Pilot
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. EOCRC patients and survivors who:

  1. reside in Utah
  2. were diagnosed with CRC at 18-49 years of age
  3. have a telephone
  4. speak English

Exclusion Criteria:

  • do not reside in Utah
  • were not diagnosed with CRC between 18-49 years of age
  • do not have a telephone
  • do not speak English

Information from the National Library of Medicine

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


Contacts
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Contact: Charles R. Rogers, PhD, MPH, MS 801-581-5752 charles.rogers@utah.edu
Contact: Melanie Steiner-Sherwood, PhD 801-213-2366 m.steiner.sherwood@utah.edu

Sponsors and Collaborators
University of Utah
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Responsible Party: Charles R. Rogers, PhD, MPH, MS, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04715074    
Other Study ID Numbers: 00138357
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing de-identified participant data stemming from cognitive interviews, surveys, intervention arms, and post trial interviews.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases