Development of a Clinical Trial Specific Question Prompt List

NCT ID: NCT00662324

Last Updated: 2013-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer Lung Cancer Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Trial experienced cancer patients and their primary caregivers.

focus groups

Intervention Type BEHAVIORAL

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.

2

Trial naive cancer patients and their caregivers.

focus groups

Intervention Type BEHAVIORAL

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.

3

Health care professionals who are involved in running Phase I, II or III clinical trials.

focus groups

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Bylund, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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NIH/NCI R03 CA130598-01

Identifier Type: -

Identifier Source: secondary_id

08-042

Identifier Type: -

Identifier Source: org_study_id

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