Evaluating Educational Materials About Cancer Clinical Trials
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 471
- Locations
- 7
- Primary Endpoint
- Change from baseline to follow-up in attitudes towards clinical trial participation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The primary objective of this project is to examine the impact of providing cancer patients with audiovisual information about clinical trials on attitudes towards clinical trial participation. It is hypothesized that patients provided these materials will have more favorable attitudes toward clinical trial participation compared to patients not provided these materials.
Participants will be randomized to either: (1) an intervention condition in which they will be asked to view a short video and read an accompanying brochure about clinical trials developed by the investigative team; or (2) a control condition in which they will be asked to read the National Cancer Institute's brochure entitled "Taking Part in Cancer Treatment Research Studies." Self-report data will be collected at two timepoints: 1) in person following study enrollment, but before receipt of material related to intervention assignment (baseline/Time 1), and 2) by telephone interview between 7 and 28 days following study enrollment (follow-up/Time 2). In addition, data will also be collected from medical records six weeks after study enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be diagnosed with cancer
- •Have not been asked previously to participate in a clinical trial of a treatment for cancer
- •Be scheduled for a visit with a medical oncologist at the time of recruitment
Exclusion Criteria
- •Are under the age of 18
- •Do not speak and read standard English
- •Are unable to provide informed consent
Outcomes
Primary Outcomes
Change from baseline to follow-up in attitudes towards clinical trial participation
Time Frame: Baseline (before first med onc visit; after first med onc visit; or before second med onc visit) and Follow-up (7-28 days after baseline)
The primary objective of this project is to examine the impact of providing cancer patients with audiovisual information about clinical trials on attitudes towards clinical trial participation. It is hypothesized that patients provided these materials will have more favorable attitudes toward clinical trial participation compared to patients not provided these materials.
Secondary Outcomes
- Impact of information on knowledge, self-efficacy, receptivity, and likelihood of participating(Baseline (before first med onc visit; after first med onc visit; or before second med onc visit) and Follow-up (7-28 days after baseline))
- Impact of information on participation in clinical trials(Medical record review (6 weeks after completion of baseline survey))