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NCT Number: NCT05701085

Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities

This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.

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Key information

Conditions

Educational Intervention Minorities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Lauren Chiec, MD

CONTACT

[email protected]

216-286-6741

About this study

The primary objective of the proposed research is to employ a non-directive method to improve preparedness for consideration of clinical trials among racial minority patients by providing tailored information to address knowledge and attitudes towards clinical trials. This model has been previously studied in a primarily white, well-educated population. It is unknown how well this model adapts to meet the needs of diverse patient populations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a diagnosis of either advanced (metastatic) cancer or early stage disease for which they are undergoing oncological work-up, treatment or surveillance
  • Participants must be at least 18 years of age
  • Participants have a non-white race or Hispanic ethnicity recorded in their patient demographics in the electronic medical record
  • Participant must have a life expectancy greater than three months based on the primary oncology team's clinical assessment.
  • Participants must be able to read and verbally communicate in English.
  • Participants must provide written informed consent.

Exclusion criteria

-

Treatment and study plan

Educational Intervention

Other

The intervention will occur at a separate dedicated in-person visit with the patient navigator estimated to last 30-45 minutes. The Pre-Intervention Survey will be scored to generate a list of barriers identified for each patient. This list of barriers will be reviewed by the patient navigator prior to the intervention date. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed.

Primary outcomes

  1. Change in knowledge regarding cancer clinical trials after the intervention

    Time frame: Up to 4 months

    Change in knowledge regarding cancer clinical trials after the intervention will be assessed by change in Pre and Post Intervention Survey Knowledge Score (scored from Items 1-8) with a higher score correlating to a greater change in knowledge.

  2. Change in attitudes regarding cancer clinical trials after the intervention

    Time frame: Up to 4 months

    A change in attitude will be recorded using changes in Pre and Post Intervention Survey Attitude Scores (scored from Items 9-21) with a higher score correlating to a greater change in attitude.

Other outcomes

  1. Rate of racial/ethnic minority participation in cancer clinical trials before and after the intervention (exploratory outcome)

    Time frame: Up tp 28 months

    Number

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Chiec, MD

CONTACT

[email protected]

216-286-6741

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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