Breast CancerNCT00662324
Development of a Clinical Trial Specific Question Prompt List
An observational study of Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- focus groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
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
- Being tested
- focus groups
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus groupsBehavioural
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.
focus groupsBehavioural
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.
focus groupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Trial experienced cancer patients and their primary caregivers. Receives: Behavioral: focus groups | |
| 2 | Trial naive cancer patients and their caregivers. Receives: Behavioral: focus groups | |
| 3 | Health care professionals who are involved in running Phase I, II or III clinical trials. Receives: Behavioral: focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.
Measured: 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.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Carmen Bylund, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662324
- Sponsor's protocol ID
- 08-042
- Other IDs
- NIH/NCI R03 CA130598-01
- Status last verified
- May 2013
- First submitted
- 17 Apr 2008
- Last updated
- 30 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Clinical Trial Specific Question Prompt List
- ClinicalTrials.gov ID
- NCT00662324
- Acronym / sponsor ID
- 08-042
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Virginia Commonwealth University
- Study start
- Apr 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: focus groupsTrial experienced cancer patients and their primary caregivers. |
| 2 | – | Behavioral: focus groupsTrial naive cancer patients and their caregivers. |
| 3 | – | Behavioral: focus groupsHealth care professionals who are involved in running Phase I, II or III clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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
- Nomination by patient as the primary caregiver
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focus groupsFocus 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. | Behavioural | 1 |
| focus groupsFocus 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. | Behavioural | 2 |
| focus groupsMSKCC 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. | Behavioural | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Bylund, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.