Assessing Barriers to Clinical Trial Participation

Sample Assessment Questions

General Questions

1. What may make it difficult for you to participate or stay enrolled in the clinical trial? ______

2. What worries or concerns do you have about this clinical trial? ______

3. What have you heard about clinical trials from family or friends? ______

4. What have you heard in the media (TV, radio, newspaper) about clinical trials? ______

5. What has been explained to you by your doctor or health provider about clinical trials? ______

Practical Barriers

Housing:

1. Where do you usually stay/live? ______

2. Do you have a permanent address? Yes no

3. What housing programs have you already applied for? ______

4. What housing assistance would you like help getting? ______

Telephone:

1. Where do you typically receive your calls? ______

2. How often is that cell phone disconnected? ______

3. How reliable is that person in giving you messages? ______

4. How much medical information can be left on the voice mail/with the person for you? ______

Health Insurance:

1. What type of health insurance coverage do you have? ______

2. How do you usually pay for medical visits? ______

3. How do you usually pay for prescription medicines? ______

4. What programs such as Medicaid or Medicare have you already applied for? ______

5. What options do you think you have to pay for your medical care? ______

Transportation

1. How do you typically get to medical appointments? ______

2. What friends/family members can you go to for help getting to a medical appointment? ______

3. How comfortable are you using public transportation? ______

Day care/eldercare

1. Are you responsible for caring for another person? Yes No

2. What options do you have for having someone else care for the person when you are at a medical visit? ______

3. How have you handled this in the past when you have to go to an appointment? ______

US Citizenship/Legal Resident Status

Ask ONLY if it is required by the clinical trial!

  1. The study requires that I ask this, do you have US citizenship, permanent or temporary legal residence?

Treatment for a Co-morbidity

1. What other medical conditions do you have? ______

2. Are you under the care of a specialist of a health care provider for a condition? Yes No

3. What health concerns do you have right now in addition to your [condition under study]? ______

Limited English Proficiency

1. In what language do you feel most comfortable speaking? ______

2. In what language do you feel most comfortable reading written materials? ______

3. Would you prefer translated materials to read? Yes No

4. Would you feel more comfortable if I bring in an interpreter? Yes No

5. What is the easiest way for you to learn new information- reading, listening, computer, video, etc?

Low Literacy Level

  1. Please tell me what you understood of my explanation about the clinical trial.
  2. Which medical or confusing terms can I explain? ______
  3. What is the easiest way for you to learn new information- reading, listening, computer, video, etc?
  4. What did you find most interesting or just learned (the person will have to explain)? ______

Lack of Understanding of the Healthcare System

1. Please tell me about past experiences when you had to get specialty medical care? ______

2. What do you find most confusing about where you get your health care? ______

3. What do you think would be most helpful for you to figure out where to go and who to call when you have a question? ______

4. What do you typically do when you need something from your health care provider? ______

Cultural Differences

1. How comfortable do you feel with your health care team? ______

2. How welcome do you feel at the places where you get your medical care? ______

3. What do you think is needed for you to feel more comfortable with your healthcare team? ______

4. How comfortable do you feel asking questions? ______

5. What can we do so you feel more comfortable asking questions and getting answers to your questions? ______

1