Clinical trial NCT04715074: #iBeatCRC: A Community-based Intervention to Increase Early-onset Colorectal Cancer Awareness
Official title: #iBeatCRC: A Community-based Intervention to Increase Early-onset Colorectal Cancer Awareness Using a Sequential Explanatory Mixed Methods Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Explanatory Mixed Methods Approach
Primary purpose: PREVENTION

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 and Wisconsin are being diagnosed with CRC. As a first step, the researchers identified the specific places in Utah and Wisconsin where diagnoses of CRC among younger people are increasing the most. Next, they conducted 1-hour recorded Zoom interviews over phone and/or video with 27 people across the United States diagnosed with CRC when they were under age 50. Thirdly, the researchers plan to create and test a program that will raise the awareness of residents in Utah and Wisconsin 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.

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 were: (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, specifically. (2) Rurality and county-level access to health care will contribute to an explanation of EOCRC incidence and survival.

Eligibility criteria: Inclusion Criteria:

Aim 1: No recruitment took place (secondary data analysis). These records were used to determine early-onset colorectal cancer hotspots in Utah.

Aim 2: 30 one-hour interviews were conducted with EOCRC patients and survivors who (1) resided in the United States, (2) were diagnosed with CRC at 18-49 years of age, (3) had a telephone, and (4) spoke English.

Aim 3: Individuals must: (1) reside in Utah or Wisconsin, (2) were diagnosed with CRC at 18-49 years of age, (3) have a telephone, and (4) speak English.

Exclusion Criteria:

Aim 1: No recruitment took place (secondary data analysis).

Aim 2: Individuals were excluded if they (1) did not reside in the United States, (2) were not diagnosed with CRC between 18-49 years of age, (3) did not have a telephone, and (4) did not speak English.

Aim 3: Individuals will be excluded if they (1) do not reside in the Utah or Wisconsin, (2) were not diagnosed with CRC between 18-49 years of age, (3) do not have a telephone, and (4) do not speak English.

Primary outcomes:
measure: EOCRC Survival Assessed by Geographic Location
timeFrame: Year 1
measure: Impact of Psychosocial, Lifestyle, and Familial Aspects on an EOCRC Diagnosis Assessed by Interviews
timeFrame: Years 2-3
measure: Impact of #iBeatCRC Mass Media Campaign on general EOCRC Awareness
timeFrame: Years 3-4
measure: Impact of #iBeatCRC Mass Media Campaign on EOCRC risk factors
timeFrame: Years 3-4
measure: Impact of #iBeatCRC Mass Media Campaign on EOCRC early detection benefit.
timeFrame: Years 3-4
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Charles R. Rogers, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers CR, Brooks E, Curtin K, De Vera MA, Qeadan F, Rogers TN, Petersen E, Gallagher P, Pesmen C, Johnson W, Henley C, Hickman W, Newcomb E, Korous KM, Handley MA. Protocol for #iBeatCRC: a community-based intervention to increase early-onset colorectal cancer awareness using a sequential explanatory mixed-methods approach. BMJ Open. 2021 Dec 3;11(12):e048959. doi: 10.1136/bmjopen-2021-048959.