Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities
Overview
- Phase
- Not Applicable
- Intervention
- Educational Intervention
- Conditions
- Educational Intervention
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Change in knowledge regarding cancer clinical trials after the intervention
- Status
- Recruiting
- Last Updated
- 25 days ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
- Not provided
Arms & Interventions
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.
Intervention: Educational Intervention
Outcomes
Primary Outcomes
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.
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.