Form 1 Instructions for Clinic Staff & Consent form

ATTACHMENT 5:

Instructions for clinic staff

obtaining consent for COntact

contact information form

study invitation script

recruitment flyer

Form Approved

OMB No. 0920-xxxx

Exp. xx/xx/xxxx

Study Title: “People Living with Lung Cancer”

Instructions for Clinic Staff: How to identify and refer eligible patients

obtaining consent for contact¹

contact information form

STUDY INVITATION SCRIPT

RECRUITMENT FLYER

The Centers for Disease Control and Prevention (CDC) and RTI International are working with Moses Cone Hospital and Scott and White Clinic to conduct interviews with people living with lung cancer. The purpose of this study is to learn more about the experiences of individuals with lung cancer, particularly with respect to their diagnosis, treatment, and the everyday challenges of living with the disease. The results of this study will help CDC develop programs that better address the needs of individuals with lung cancer.

Individuals who meet the following criteria are eligible for this study:

• Diagnosed with lung cancer

• At least 6 months since first diagnosis

• Between the ages of 30 and 80

• Able to complete an interview in English

• Not currently participating in cancer-related research studies

We are asking for your assistance in identifying patients with lung cancer who may fit the eligibility criteria listed above -- particularly patients with lung cancer who NEVER SMOKED.

If you identify a potentially eligible patient, please do the following:

• Ask the patient verbally if he or she is interested in being contacted about the study. Use the Study Invitation Script, provided on the next page of these instructions, to guide the conversation.

• Provide the patient with the Recruitment Flyer for this study.

• Obtain Consent for Contact and a HIPAA authorization, if required by your clinic.

• Obtain the patient’s contact information using the Contact Information Form.

• Forward the signed Consent for Contact, the completed Contact Information Form, and the HIPAA authorization to the RTI Study Coordinator.

Thank you for your assistance in identifying patients who may be interested in learning more about this research study.

Study Title: “People Living with Lung Cancer”

Study Invitation Script [Delivered by Clinic Staff to Potential Research Participant]

Mr./Mrs./Ms./Dr. __________________. The Centers for Disease Control and Prevention (CDC), in collaboration with [Name of Health Center] and RTI International, is interviewing people living with lung cancer. They are doing interviews as part of a study to learn more about the experience and needs of people living with lung cancer. I see from your record that you may be eligible to participate in an interview.

Here is information on the study. [Present Recruitment Flyer] It is not a treatment study and your decision to take part or not would not change the care you receive from us.

You would be asked to do a telephone interview. In the interview, you would be asked questions about your diagnosis, treatment, and the everyday challenges of living with lung cancer. This study is to help CDC develop programs for individuals with lung cancer. If you qualify and take part, you would receive $75 for any costs incurred in participating.

If you are interested in participating in this study, I would need to gather some contact information and then get you to sign a form with your signature authorizing the RTI study coordinator to contact you about participation.

You are only agreeing to be contacted about participating in the study. You may choose to participate or not after being contacted. A study coordinator from RTI will follow-up with a call and potentially set up a time to conduct the interview. [If person agrees to be contacted, complete contact information at the end of this form]

[If required by the local site] I also need you to sign this authorization form that lets us release your personal information about having been diagnosed with lung cancer to the study coordinator.

If a patient is not sure about participating, provide the Recruitment Flyer and let them know that if they decide later that they are interested in participating, they can use the contact information at the bottom of the flyer to reach someone about participating.

1 This consent for contact process will be done in person