Clinical Trial
Conditions
Keywords
minority group recruitment, stages of implementation, clinical trials education
Brief summary
This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. This study will also determine the feasibility of implementing an office-based video educational program.
Detailed description
Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows: 1. Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. 2. Determine the feasibility of implementing an office-based video educational program.
Interventions
PROCEDUREVideo viewing group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
Sponsors
National Cancer Institute (NCI)
Meharry-Vanderbilt Alliance
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation
Exclusion criteria
* Previous history of clinical trial research participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| study feasibility | 12 months | The stages of implementation completion (SIC) measure will be used as an internal tool utilized by the study team to track time to achievement of key implementation milestones. An 8-stage implementation plan to measure feasibility of the office-based educational program will be executed across 3 phases. Three scores will be derived from the SIC measure. The first score is the number of stages completed. The second score is the time spent at each stage. The third score is the proportion of activities completed at each stage. Implementation of the SIC model poses no additional burden on study participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical trial participation | 12 months | Information on clinical trial participation will be collected by a team member by reviewing the participants' health record and by contacting the VICC clinical trial team. |
| Clinical trial knowledge survey | 7-10 days | This survey consist of 22-items assessing a participants views on clinical trials on 5 domains (positive beliefs, safety, information needs, negative expectations, and patient involvement). |
| Likelihood to participate survey | 7-10 days | This survey consist of 5-items assessing reasons for not participating in research, views about sources of research, views about sharing of research data, trust, and willingness to advise research teams. |
Countries
United States
Outcome results
None listed