Development of a Clinical Trial Specific Question Prompt List

Completed

• Conditions: Breast Cancer; Lung Cancer; Prostate Cancer
• Interventions: Behavioral: focus groups

• Registration Number: NCT00662324
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-21
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.	conclusion of study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States