CLINICAL TRIAL

Education presented by trained caregiver for Colorectal Cancer

Recruiting · 18 - 65 · All Sexes · Cleveland, OH

Educate, Assess Risk and Overcoming Barriers to Colorectal Screening Among African Americans

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About the trial for Colorectal Cancer

Eligible Conditions
Colorectal Neoplasms · Colorectal Carcinoma (CRC)

Treatment Groups

This trial involves 2 different treatments. Education Presented By Trained Caregiver is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Education presented by trained caregiver
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Although this program may ultimately include all races as a community outreach event, we will not analyze the data of non-African Americans. show original
The CRC colonoscopy screening program is meant for African American individuals who are 45 to 75 years old and have not had a screening colonoscopy in the past 10 years show original
The education only targeting of African American individuals 18 years and older is a clear attempt to restrict the right to vote on the basis of race show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At the end of education - 24 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: At the end of education - 24 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At the end of education - 24 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Education presented by trained caregiver will improve 1 primary outcome and 6 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of From baseline (week 0) to follow-up end of study (week 24).

Difference in paired pre-/post-test score
FROM BASELINE (WEEK 0) TO FOLLOW-UP END OF STUDY (WEEK 24)
16 item knowledge questions, where each item is assessed as true, false, or not sure. A 25% improvement of knowledge between pre- and post-test scores will indicate an effective program
FROM BASELINE (WEEK 0) TO FOLLOW-UP END OF STUDY (WEEK 24)
Fidelity of intervention
AT THE END OF EDUCATION - 24 WEEKS
Number of documented deviations throughout the program. 90% of the 11-step program needs to be followed. A 'deviation' would be defined as not adhering to one of the 11 steps.
AT THE END OF EDUCATION - 24 WEEKS
Percentage of participants who found the Risk assessment questionnaire helpful
AT THE END OF EDUCATION - 24 WEEKS
Metrics will be measured on a 5-point scale where the two most favorable categories (i.e. strongly agree and agree) will be considered a positive response.
AT THE END OF EDUCATION - 24 WEEKS
Feasibility of Intervention
AT THE END OF EDUCATION - 24 WEEKS
Measured by evaluating practicality or logistics of the proposed interventional program with 8 item dichotomous questionnaire. A 100% positive response on the questionnaire (all 8 items answered 'yes') will be considered a 'positive' questionnaire for an individual participant. If 80% of participants respond with an overall 'positive' questionnaire, the study will be considered feasible.
AT THE END OF EDUCATION - 24 WEEKS
Acceptability of intervention
AT THE END OF EDUCATION - 24 WEEKS
Metrics (convenient, appropriate, effective, satisfaction) will be measured on a 5-point scale where the two most favorable categories (i.e. strongly agree and agree) will be considered a positive response.
AT THE END OF EDUCATION - 24 WEEKS
Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
AT THE END OF EDUCATION - 24 WEEKS
Percentage of individuals aged 45-75 who have never had colon or rectal cancer screening
AT THE END OF EDUCATION - 24 WEEKS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes colorectal cancer?

We discuss the theories as to the cause of colorectal cancers and the role of viruses, inorganic and microbial. There is an urgent need to develop accurate and effective measures to prevent colorectal cancer.

Anonymous Patient Answer

Can colorectal cancer be cured?

Although [colon cancer](https://www.withpower.com/clinical-trials/colon-cancer) is relatively curable if detected and treated early, about 24% of patients ultimately die of the disease. This number is even higher if the disease progresses, and even higher still if the cancer recurs. Most survivors succumb to other complications of the disease rather than to cure.

Anonymous Patient Answer

What is colorectal cancer?

Colorectal cancer is an uncommon cancer of the colon and rectum of the adult. It often spreads to other parts of the body via the lymphatic system, the circulatory system, or the bloodstream. It is the seventh most common cancer in the United Kingdom. The cause of colorectal cancer is uncertain.

Anonymous Patient Answer

What are the signs of colorectal cancer?

Symptoms of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) may present with blood loss, weight loss, altered stool form, unexplained bleeding or pain. Patients may experience bowel obstruction or bloating. Patients also may have fever, night sweats or night perspiration. The onset of symptoms often occurs over a relatively long period of time and does not follow a predictable pattern. Patients often are asymptomatic or have a family history for colorectal cancer. There is usually no specific presentation that is associated with colorectal cancer. Patients with colorectal cancer may be screened for polyps, cancers and familial adenomatous polyposis on the basis of their unexplained colonic symptoms. Screening depends on patients age.

Anonymous Patient Answer

How many people get colorectal cancer a year in the United States?

This is the first study to report annual incidence of colorectal and cancer, the first study to examine incidence of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) by age category, and the first study to establish incidence rates of colorectal cancer in the United States by race/ethnicity. In a recent study, findings revealed incidence of colorectal cancer was 4.1 colon cancer and 1.0 rectum cancer in 1000 people. Each year during the 5-year interval, 13,910 cases were diagnosed with rectal cancer and 4,720 with colon cancer. In addition, the incidence rates of colon cancer per 1,000 persons per year for the total study group were 2,867 for women and 5,843 for men.

Anonymous Patient Answer

What are common treatments for colorectal cancer?

The most common treatment for colorectal cancer is surgery, followed by chemotherapy, radiotherapy, and medical management by oncologists. On occasion, patients receive palliative care and end-of-life care. Overall survival for colorectal cancer is relatively poor, so patients must be encouraged to exercise regularly and to engage in low-fat diets.

Anonymous Patient Answer

Has education presented by trained caregiver proven to be more effective than a placebo?

Considering the higher percentage of women and the fact that most colorectal cancer is detected at a stage when surgery is not an option, we decided to use the intervention presented by a caregiver. The caregiver was a trained and supervised representative of the patient, who can be consulted about medical conditions, and also receive medical instructions with respect to the patient’s disease and rehabilitation plan. A caregiver who has been trained and who has been carefully selected for the study represents a highly valuable and effective link between the patient and health professionals. The intervention was a simple one: an on-leisure session in which the patient read a short booklet, translated to Dutch, about colorectal cancer and prevention.

Anonymous Patient Answer

What are the chances of developing colorectal cancer?

On the other hand, there are several factors that play a role in the disease's development, some of which are controllable. The first thing that is controllable is stopping the habit of smoking, especially in men. This can help protect men from the development of this type of cancer, because smoking is a major risk factor for the disease. An increase in red and processed meat consumption could also contribute to colorectal cancer development. The more meat that is eaten in a day the higher the risk of the disease onset. I want to clarify the other controllable factors that affect colorectal cancer. Let’s see how you can avoid this type of cancer.

Anonymous Patient Answer

What is the average age someone gets colorectal cancer?

The age of onset, or age of diagnoses are not an indicator of the age at which the disease starts to develop. In a recent study, findings clearly indicates that an average age of onset of age is not an indicator of the overall age of diagnosing.

Anonymous Patient Answer

What is the latest research for colorectal cancer?

Thank you so much for that question. There are some recent studies on [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer). It can be found here: https://web.archive.org/web/20070912203337/http://www.researchdiscovery.net/articles/Colorectal_ cancer.html There also a colorectal cancer awareness month. The month of October in the US. If you want to have more information on colorectal cancer awareness month, just search it on the web of your choice. And, hopefully, you can have better choice of choosing a healthy diet, regular physical activity, and avoiding smoking.

Anonymous Patient Answer

Is education presented by trained caregiver safe for people?

The education of healthcare professionals regarding FOLFOX improves knowledge and accuracy in assessing bowel function. It also leads, and will inevitably lead to, increased use of this therapy.

Anonymous Patient Answer

What is the primary cause of colorectal cancer?

Results from a recent paper suggest that, for colorectal cancer, the major causative factor is likely to be other than the sporadic genotypes and environmental factors, and that the aetiology of colorectal cancer is complicated.

Anonymous Patient Answer
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