Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation

This study is not yet open for participant recruitment.
Verified October 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01964222
First received: October 7, 2013
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Cancer
Behavioral: Decision Aid (DA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Knowledge about cancer clinical trials [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
    A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.


Secondary Outcome Measures:
  • Self-efficacy for communicating about cancer clinical trials [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
    A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.

  • Attitudes about cancer clinical trials [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
    A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.

  • Satisfaction with the information presented [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
    A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.

  • Confidence in choice [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
    A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.


Estimated Enrollment: 180
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decision Aid (DA)
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Behavioral: Decision Aid (DA)
Participants will be shown (on a tablet computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care (access to the Siteman Cancer Center's website about clinical trials).
No Intervention: Control
Participants randomized to the control group will receive usual care (access to Siteman Cancer Center's website about clinical trials).

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 and access to the Siteman Cancer Center website about 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with cancer in the past 6 months
  • English speaking
  • At least 18 years old

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01964222

Contacts
Contact: Mary C Politi, PhD 314-747-1967 mpoliti@wustl.edu
Contact: Summer C Roberts, MA 314-747-1968 robertss@wudosis.wustl.edu

Locations
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of Miami
Investigators
Principal Investigator: Mary C Politi, PhD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01964222     History of Changes
Other Study ID Numbers: 201309076
Study First Received: October 7, 2013
Last Updated: October 16, 2013
Health Authority: United States: Washington University School Medicine IRB and Siteman Cancer Center Protocol Review Committee

Keywords provided by Washington University School of Medicine:
Cancer
Clinical trials
Informed consent
Health literacy

ClinicalTrials.gov processed this record on April 16, 2014