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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01964222
First Posted: October 17, 2013
Last Update Posted: December 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Miami
Information provided by (Responsible Party):
Washington University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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) ]
    A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as "Only very sick patients are asked to take part in a cancer research study" and "Cancer research studies almost never involve the use of a placebo or sugar pill alone". Participants will indicate each item as "True", "False", or "I don't know". An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire.

  • Clarity of Values [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ]
    A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall "values clarity" score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire.

  • Uncertainty in Choice [ Time Frame: 1 day Immediately following either showing the participant the experimental or control information (same day) ]
    A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall "uncertainty" score from 0 to 100. Higher values represent more uncertainty. 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) ]
    A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. 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) ]
    A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.


Enrollment: 201
Study Start Date: May 2014
Study Completion Date: July 2015
Primary Completion Date: May 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 computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
No Intervention: Control
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964222


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:
Office of Human Research Protections (OHRP): Compliance Determination Letters. US Department of Health and Human Services. Washington, DC: 2002.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01964222     History of Changes
Other Study ID Numbers: 201309076
First Submitted: October 7, 2013
First Posted: October 17, 2013
Results First Submitted: September 25, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015
Last Verified: November 2015

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