Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT05701085

Conditions

Educational Intervention

Minorities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational Intervention

Study Details

Brief summary:

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.

Conditions

Educational Intervention

Minorities

Study ID

NCT05701085

Start date

Apr 24, 2023

Status verified date

Apr, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

\-

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PRE-ACT Adaptation

At the scheduled oncologic visit: consent obtained and all participants will complete the Demographics/Clinical Characteristics survey and Pre-Intervention Survey

Within 3 months of consent: tailored educational intervention and patient navigation program will take place and the scored Pre-Intervention survey will be used to generate a list of barrier for each patient. 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.

Within 4 weeks of the educational video: the participant will be contacted via phone to complete a Post-Intervention Survey that assesses knowledge, attitudes, and preparation related to participation in clinical trials

Two years after intervention: chart review will be performed to assess if the patient participated in a clinical trial.

Interventions

Educational Intervention

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 outcome measure

  • Change in knowledge regarding cancer clinical trials after the intervention [ Time Frame: Up to 4 months ]
  • Change in attitudes regarding cancer clinical trials after the intervention [ Time Frame: Up to 4 months ]

Central Contacts and Locations

Central contacts

Lauren Chiec, MD

216-286-6741lauren.chiec@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Lauren Chiec, MD

216-286-6741lauren.chiec@uhhospitals.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • PRE-ACT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-04-07.