Official Title: “Development of a Clinical Trial Specific Question Prompt List”

The purpose of this study is to develop a Question Prompt List (QPL) about clinical trials for cancer patients and find out what cancer patients and their caregivers think of the QPL.

A QPL is a list of questions patients might want to ask their doctors during their appointments.

We will conduct three focus groups to talk about using QPL's as a new way to recruit patients like you to clinical trials. The three groups will be made of patients who have and have not participated in clinical trials, their caregivers and doctors. This study is also being done to learn about how the QPL affects the question asking behavior of patients during their appointments with doctors at Memorial SloanKettering Cancer Center (MSKCC).

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Behavioral: focus groups
  • Focus group with MSKCC patients with lung, breast and prostate cancer who have taken part in clinical trials and other caregivers. This focus group will be audio recorded. During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would have been useful to the patient you care for in his/her experience in a clinical trial. The focus group to last from 60 to 90 minutes.
• Behavioral: focus groups
  • Focus group with MSKCC patients with lung, breast and prostate cancer who have not taken part in clinical trials and other caregivers. This focus group will be audio recorded. During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful if the patient you care for were ever to take part in a clinical trial sometime in the future. We expect the focus group to last from 60 to 90 minutes.
• Behavioral: focus groups
  • MSKCC clinicians who work with lung, breast and prostate cancer patients. This focus group will be audio recorded. During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful to your patients who take part in clinical trials. Expect the focus group to last from 60 to 90 minutes.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Trial experienced cancer patients and their primary caregivers.
• : 2
  • Trial naive cancer patients and their caregivers.
• : 3
  • Health care professionals who are involved in running Phase I, II or III clinical trials.

Primary Measures

• To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.
  • Time Frame: conclusion of study
    Safety Issue?: No

Secondary Measures

• To explore the utility of the Question Prompt List for Clinical Trials in oncology consultations containing a discussion of a Phase I, II or III clinical trial.
  • Time Frame: conclusion of study
    Safety Issue?: No

Inclusion Criteria:

• Population Segment 1 who have participated in a clinical trial
• Diagnosis and treatment at MSKCC of lung, prostate or breast cancer
• Completion of a Phase I, II, or III clinical trial at MSKCC
• Ability to provide informed consent

Patient caregiver eligibility requirements will be:

• Nomination by patient as the primary caregiver
• Ability to provide informed consent

Population Segment 2 who have not participated in a clinical trial:

• Diagnosis and treatment at MSKCC of lung, prostate or breast cancer or the primary patient caregiver
• Ability to provide informed consent

Patient caregiver eligibility requirements will be:

• Nomination by patient as the primary caregiver
• Ability to provide informed consent

Population Segment 3 who are health care professionals:

• A current health care professional at MSKCC
• Current involvement in recruiting patients with lung, prostate or breast cancer to Phase I,II, or III clinical trials at MSKCC
• Ability to provide informed consent

Exclusion Criteria:

• Potential subjects will be considered ineligible for either/both phases of this study if they are:
• Fewer than 18 years of age
• Cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study
• Population Segment 2 participants will be excluded if they have ever participated in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Richard Brown, PhD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Overall Contact: Richard Brown, PhD  brownr@mskcc.org

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662324

Study ID Number: 08-042

ClinicalTrials.gov Identifier: NCT00662324

Health Authority: United States: Institutional Review Board

Memorial Sloan-Kettering Cancer Center