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

NCT04863092 | Completed DMC

• 2 other identifiers: 20-0590.ccP30CA046934
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in number of underrepresented patients participating in cancer related therapeutic CTs

  36 months

• Identify relationships between sociodemographic variables and the attitudes towards CTs

  36 months

Other Outcomes (4)

• PN-referred persons screened for cancer related therapeutic CTS;

  36 months

• PN-referred persons enrolled in related therapeutic CTS;

  36 months

• connected to care services such as health insurance, treatment assistance programs

  36 months

Study Arms (1)

Underrepresented Population

EXPERIMENTAL

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

Behavioral: Educational Intervention

Interventions

Educational Intervention 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.

Underrepresented Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be over 18 years old
• English and/or Spanish Speaking

You may not qualify if:

• Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \[at the discretion of the CHE or PN upon recruitment\];
• 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 \[at the discretion of the CHE or PN upon recruitment\];
• Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment \[at the discretion of the CHE or PN upon recruitment\].
• Individuals under the age of 18 years.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Evelinn Borrayo, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It uses a pre- and post-design to evaluate participants' changes in knowledge of and intentions to in CTs by comparing outcomes at baseline to outcomes after exposure to the CHE educational intervention.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: November 24, 2020
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)