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Completed

NCT Number: NCT01964222

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision Aid (DA)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Miami

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2013
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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