Expired Study
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New York, New York 10065


Purpose:

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).


Criteria:

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 is Available At:


Original ID:

08-042


NCT ID:

NCT00662324


Secondary ID:

NIH/NCI R03 CA130598-01


Study Acronym:


Brief Title:

Development of a Clinical Trial Specific Question Prompt List


Official Title:

Development of a Clinical Trial Specific Question Prompt List


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

67


Enrollment Type:

Actual


Overall Contact Information

Official Name:Carmen Bylund, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:April 2008
Completion Date:May 2013
Completion Type:Actual
Primary Completion Date:May 2013
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 29, 2013
First Received Date:April 17, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 Issues:False
Outcome Type:Secondary Outcome
Measure: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 Issues:False

Study Interventions

Intervention Type:Behavioral
Name:focus groups
Description: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.
Arm Name:1
Intervention Type:Behavioral
Name:focus groups
Description: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 mi
Arm Name:2
Intervention Type:Behavioral
Name:focus groups
Description: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.
Arm Name:3

Study Arms

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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Samples and Retentions

Study Population: treatment at MSKCC of lung, prostate or breast cancer 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
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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