Intervention to Educate and Improve Underrepresented Populations' Participation in Clinical Trials

Cancer Clinical Trial

Official title:

Intervention to Educate and Improve Underrepresented Populations' Participation in Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863092
• Other study ID #: 20-0590.cc
• Secondary ID: P30CA046934
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: March 23, 2025

Study information

• Verified date: June 2023
• Source: University of Colorado, Denver
• Contact: Jose Barron
• Phone: 303-724-5439
• Email: jose.barron[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposal aims to leverage ongoing community outreach efforts and the Cancer Center's aims to improve recruitment to clinical trials by educating the catchment and making referrals to engage current UCCC patients not taking advantage of available CTs at this institution and affiliated hospitals. The Cancer Prevention and Control Program within UCCC works to develop and evaluate novel approaches to primary prevention, disseminate preventative interventions in population-based settings, and to improve health services delivery and outcomes for cancer patients and survivors. A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty. Efforts to meet the Cancer Center's priorities include interventions to promote awareness and recruitment of eligible patients to available CTs in the catchment area (the state of Colorado).

Description:

Clinical Trial Education Intervention: The educational intervention will be delivered to approximately 200 participants by the Community Health Educators (CHEs) who will conduct workshops to deliver content and educational materials to patients about the importance of participating in cancer clinical trials. The workshops will last approximately 60 minutes, with 20 minutes to educate participants and 10 minutes to discuss the materials and answer any questions. Prior to and after the presentation, the CHE will administer the pre- and post-intervention survey to participants. Group sizes will be capped to 25 individuals per group. Additionally, the CHE and/or Patient Navigators (PNs) will set up pathways for communication with key personnel (i.e. nurse navigators, clinical research coordinators, investigators) from partnering hospitals and clinics to facilitate patient referrals and evaluation for eligibility for clinical trials. The CHE and/or PN will keep track of those individuals that are referred by the partner hospital and clinics to track if the PN referral resulted in enrollment and participation in a clinical trial. The CHE and/or PN will also record and report quarterly the number of: (a) persons referred to therapeutic/intervention CTs at the UCCC and partnering hospitals; (b) referred persons screened for therapeutic/intervention CTs at the UCCC and partnering hospitals; (c)referred persons enrolled in therapeutic/ intervention CTs at the UCCC and partnering hospitals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 23, 2025
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision to sign and date the consent form.

2. Stated willingness to comply with all study procedures and be available for the duration of the study.

3. Be over 18 years old

4. English and/or Spanish Speaking

Exclusion Criteria:

1. Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish [at the discretion of the CHE or PN upon recruitment];

2. Decisionally-challenged adults with cognitive or personality impairment or due to intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study [at the discretion of the CHE or PN upon recruitment];

3. Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment [at the discretion of the CHE or PN upon recruitment].

4. Individuals under the age of 18 years.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Educational Intervention
The workshops will last approximately 60 minutes, with 20 minutes to educate participants and 10 minutes to discuss the materials and answer any questions. Prior to and after the presentation, the CHE will administer the pre- and post-intervention survey to participants. Group sizes will be capped to 25 individuals per group.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PN-referred persons screened for cancer related therapeutic CTS;	The number of patients who interact with the site and connect with the PN for other services.	36 months
Other	PN-referred persons enrolled in related therapeutic CTS;	The number of patients who interact with the site and connect with the PN for other services.	36 months
Other	connected to care services such as health insurance, treatment assistance programs	The number of patients who interact with the site and connect with the PN for other services.	36 months
Other	facilitate other services such as language translation, appointment scheduling, transportation, and childcare.	The number of patients who interact with the site and connect with the PN for other services.	36 months
Primary	Change in knowledge and understanding of and intent to participate in Clinical Trials (CTs)	Using questionnaires to measure the change in knowledge of and understanding and intent to participate in CTs	36 months
Primary	Number of patients referred, screened, and enrolled into cancer related therapeutic CTs	Monitoring the number of referrals to and enrollment in CTs will help determine effectiveness of educational materials.	36 months
Secondary	Change in number of underrepresented patients participating in cancer related therapeutic CTs	In collaboration with the Cancer Clinical Trials Office (CCTO), the investigators will obtain quarterly demographic data for all participants across all clinical trials within the system and affiliate hospitals	36 months
Secondary	Identify relationships between sociodemographic variables and the attitudes towards CTs	For future studies, this can help provide insight as to what sociodemographic variables to target to increase CTs enrollment in the catchment area	36 months