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

NCT ID: NCT04863092

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2024-08-05

Brief 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).

Detailed 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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Underrepresented Population

A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty

Group Type: EXPERIMENTAL

Educational Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelinn Borrayo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-0590.cc

Identifier Type: -

Identifier Source: org_study_id