Clinical trial NCT01964222: Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Clinical trials
Informed consent
Health literacy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2013-10-17
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Knowledge About Cancer Clinical Trials
timeFrame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
measure: Clarity of Values
timeFrame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
measure: Uncertainty in Choice
timeFrame: 1 day Immediately following either showing the participant the experimental or control information (same day)
Secondary outcomes:
measure: Self-efficacy for Communicating About Cancer Clinical Trials
timeFrame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
measure: Attitudes About Cancer Clinical Trials
timeFrame: 1 day (Immediately following either showing the participant the experimental or control information (same day)
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Siteman Cancer Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary C Politi, PhD
role: PRINCIPAL_INVESTIGATOR
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