Clinical trial NCT00662324: Development of a Clinical Trial Specific Question Prompt List
Official title: Development of a Clinical Trial Specific Question Prompt List
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lung Cancer
Prostate Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: Virginia Commonwealth University
First posted: 2008-04-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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).


Eligibility 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.

Primary outcomes:
measure: To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.
timeFrame: conclusion of study
Secondary outcomes:
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.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Carmen Bylund, PhD
role: PRINCIPAL_INVESTIGATOR
References: