Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Educational Intervention.
- Who it may be relevant to
- Registry conditions: Educational Intervention, Minorities. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort Study of a Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making About Clinical Trials Among Racial and Ethnic Minorities
Overview
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.
Interventions
- Other 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
Primary outcome measures
- 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]
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
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland
Identifiers
NCT: NCT05701085 · CASE3522