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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Decision Aid (DA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid (DA)<br>The decision aid (DA) will be provided to patients randomized to the experimental/intervention group. | Behavioral: Decision Aid (DA)<br>* 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.<br>|
| No Intervention: Control<br>Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge About Cancer Clinical Trials | 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. | 1 day (Immediately following either showing the participant the experimental or control information (same day) | 
| Clarity of Values | 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. | 1 day (Immediately following either showing the participant the experimental or control information (same day) | 
| Uncertainty in Choice | 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. | 1 day Immediately following either showing the participant the experimental or control information (same day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for Communicating About Cancer Clinical Trials | 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. | 1 day (Immediately following either showing the participant the experimental or control information (same day) | 
| Attitudes About Cancer Clinical Trials | 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. | 1 day (Immediately following either showing the participant the experimental or control information (same day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Clinical trials, Informed consent, Health literacy