N/A
N=201
Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01964222 ↗Enrolled (actual)
201
Serious AEs
—
Results posted
Dec 2015
Primary outcome: Primary: Knowledge About Cancer Clinical Trials — 73.4; 61.6 percentage questions answered correctly
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Aid (DA) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Knowledge About Cancer Clinical Trials |
73.4; 61.6 | — |
| PRIMARY Clarity of Values |
16.6; 33 | — |
| PRIMARY Uncertainty in Choice |
23; 33.2 | — |
| SECONDARY Self-efficacy for Communicating About Cancer Clinical Trials |
4.1; 3.5 | — |
| SECONDARY Attitudes About Cancer Clinical Trials |
3.8; 3.8; 3.7; 3.7 | — |
Summary
This study will update an existing health literacy intervention (decision aid) for informed consent procedures and then conduct a randomized experiment implementing the health literacy intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care. Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to usual care will increase knowledge about cancer clinical trials. Secondary outcomes include patients' ability to communicate with health care providers about trials, willingness to participate in trials, and enrollment rates for minority participants.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with cancer in the past 6 months
- English speaking
- At least 18 years old
Exclusion Criteria
- Past participation in a clinical trial for treatment
Data sourced from ClinicalTrials.gov (NCT01964222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.