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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Educational Intervention

    Other 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.

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: PRE-ACT AdaptationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in knowledge regarding cancer clinical trials after the intervention

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.

Time frame
Up to 4 months
2

Change in attitudes regarding cancer clinical trials after the intervention

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.

Time frame
Up to 4 months

Secondary outcomes

Other outcomes

1

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

Number

Time frame
Up tp 28 months

Sponsors and contacts

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