Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2014 |
| End Date: | July 2015 |
A Mixed Methods Study to Reduce Disparities in Cancer Clinical Trials by Adapting a Health Literacy Intervention for Informed Consent and Comparing it to Usual Care in a Randomized Experiment
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.
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.
A previously developed and pilot tested web-based decision aid (DA) based on best practices
in health literacy that is well received by minority participants and significantly improved
knowledge about cancer clinical trials and decision self-efficacy will be used. This study
will expand the reach of the DA and test it in a larger study in a different geographic
region and center (Siteman Cancer Center). An additional benefit of conducting this work at
Siteman Cancer Center is that Siteman and the Program for the Elimination of Cancer
Disparities (PECaD) already institute structural changes at the system level to improve
minority participation in trials. This study will activate and educate patients and will
complement the system-level interventions.
By random 1:1 assignment, 180 participants will either receive:
*Targeted, web-based decision aid (DA) about participating in cancer clinical trials.
or
*Usual care/control-Access to the Siteman Cancer Center website about clinical trials.
Outcomes from the DA group will be compared to outcomes in a usual care/control group.
in health literacy that is well received by minority participants and significantly improved
knowledge about cancer clinical trials and decision self-efficacy will be used. This study
will expand the reach of the DA and test it in a larger study in a different geographic
region and center (Siteman Cancer Center). An additional benefit of conducting this work at
Siteman Cancer Center is that Siteman and the Program for the Elimination of Cancer
Disparities (PECaD) already institute structural changes at the system level to improve
minority participation in trials. This study will activate and educate patients and will
complement the system-level interventions.
By random 1:1 assignment, 180 participants will either receive:
*Targeted, web-based decision aid (DA) about participating in cancer clinical trials.
or
*Usual care/control-Access to the Siteman Cancer Center website about clinical trials.
Outcomes from the DA group will be compared to outcomes in a usual care/control group.
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
We found this trial at
1
site
Siteman Cancer Center The Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University...
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