Development of a Clinical Trial Specific Question Prompt List
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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 |
- 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 ]
- 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 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (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 |
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
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| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| 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: | January 31, 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 May 19, 2013