Development of a Clinical Trial Specific Question Prompt List

Breast Cancer Clinical Trial

Official title:

Development of a Clinical Trial Specific Question Prompt List

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662324
• Other study ID #: 08-042
• Secondary ID: NIH/NCI R03 CA13
• Status: Completed
• Phase: N/A
• First received: April 17, 2008
• Last updated: May 29, 2013
• Start date: April 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Prostate Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH), Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.		conclusion of study	No
Secondary	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.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center