Development of a Clinical Trial Specific Question Prompt List

NCT00662324 | Completed

• 2 other identifiers: 08-042NIH/NCI R03 CA130598-01
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Lung Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

1

Trial experienced cancer patients and their primary caregivers.

Behavioral: focus groups

2

Trial naive cancer patients and their caregivers.

Behavioral: focus groups

3

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

Behavioral: focus groups

Interventions

focus groups 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Virginia Commonwealth University: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carmen Bylund, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)