Development of a Clinical Trial Specific Question Prompt List

This study has been completed.
Sponsor:
Collaborators:
Virginia Commonwealth University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00662324
First received: April 17, 2008
Last updated: May 29, 2013
Last verified: May 2013
  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).


Condition Intervention
Breast Cancer
Lung Cancer
Prostate Cancer
Behavioral: focus groups

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Clinical Trial Specific Question Prompt List

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: April 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Trial experienced cancer patients and their primary caregivers.
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.

2
Trial naive cancer patients and their caregivers.
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.

3
Health care professionals who are involved in running Phase I, II or III clinical trials.
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662324

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Virginia Commonwealth University
Investigators
Principal Investigator: Carmen Bylund, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00662324     History of Changes
Other Study ID Numbers: 08-042, NIH/NCI R03 CA130598-01
Study First Received: April 17, 2008
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014