Lung CancerNCT01466946
Understanding Symptom Recognition and Treatment Decision-making in Hispanic/Latino Lung Cancer Patients
An observational study of Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of the study is to understand why Hispanic/Latino patients with lung cancer are diagnosed later than other groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC.
Who may be able to join
- Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC, including stages of disease I-IV
- 18 years of age or older
- Fluent in English or Spanish
- Patients must reside in the U.S
Who cannot join
- Spanish-surnamed patients who do not self identify as Hispanic/Latino (e.g., Philippines-born individuals)
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 the study is to understand why Hispanic/Latino patients with lung cancer are diagnosed later than other groups.
- Conditions
- Lung Cancer
- Being tested
- semi-structured interviews
- Keywords
- lung cancer, Hispanic/Latino patients, interviews, 11-109
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsBehavioural
Use semi-structured interview methods to gather narrative data from research participants, as more open-ended interviews allow participants to share information that is most relevant to their own experiences (Patton, 2002; Rubin \& Rubin, 2005; Kvale, 1996). Semi-structured interviewing can generate a rich understanding of a participant's life routines, experiences, and attitudes related to a topic of inquiry, and can yield a nuanced and thorough description of a research participant's life story and belief systems.
| Study group | Role | What they receive |
|---|---|---|
| semi-structured interviews | A qualitative study of MSKCC lung cancer patients of Hispanic/Latino descent by collecting retrospective patient narratives to understand the processes that led them to seek medical help when they did, their experiences in seeking and receiving medical guidance, as well as their decisions regarding lung cancer treatment. In addition, we will explore how these patients' representations of lung cancer with its associated risk factors and symptoms affected their treatment decisions. Receives: Behavioral: semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychosocial issues
related to lung cancer symptom recognition, delays in lung cancer diagnosis of Hispanic/Latino patients and treatment decision-making processes.
Measured: 2 years
cultural issues
related to lung cancer symptom recognition, delays in lung cancer diagnosis of Hispanic/Latino patients and treatment decision-making processes.
Measured: 2 years
Secondary outcomes (1)
identify obstacles
that have been overcome by Hispanic/Latino lung cancer patients who have succeeded in obtaining access to care at an NCI-designated cancer center, and probe for barriers that these individuals believe still need to be addressed or that they were not successful in surpassing.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Sophie Davis School of Biomedical Education The City College of New York, City University of New York
- Responsible party
- Sponsor
- Investigators
- William Alago, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466946
- Sponsor's protocol ID
- 11-109
- Status last verified
- Feb 2016
- First submitted
- 4 Nov 2011
- Last updated
- 11 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Symptom Recognition and Treatment Decision-making in Hispanic/Latino Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01466946
- Acronym / sponsor ID
- 11-109
- Conditions
- Lung Cancer
- Keywords
- lung cancer, Hispanic/Latino patients, interviews, 11-109
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- The Sophie Davis School of Biomedical Education The City College of New York, City University of New York
- Study start
- Nov 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Nov 2011 (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 the study is to understand why Hispanic/Latino patients with lung cancer are diagnosed later than other groups.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| semi-structured interviews | – | Behavioral: semi-structured interviewsA qualitative study of MSKCC lung cancer patients of Hispanic/Latino descent by collecting retrospective patient narratives to understand the processes that led them to seek medical help when they did, their experiences in seeking and receiving medical guidance, as well as their decisions regarding lung cancer treatment. In addition, we will explore how these patients' representations of lung cancer with its associated risk factors and symptoms affected their treatment decisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC.
Key inclusion criteria (4 listed)
- Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC, including stages of disease I-IV
- 18 years of age or older
- Fluent in English or Spanish
- Patients must reside in the U.S
Key exclusion criteria (1 listed)
- Spanish-surnamed patients who do not self identify as Hispanic/Latino (e.g., Philippines-born individuals)
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 |
|---|---|---|
| semi-structured interviewsUse semi-structured interview methods to gather narrative data from research participants, as more open-ended interviews allow participants to share information that is most relevant to their own experiences (Patton, 2002; Rubin \& Rubin, 2005; Kvale, 1996). Semi-structured interviewing can generate a rich understanding of a participant's life routines, experiences, and attitudes related to a topic of inquiry, and can yield a nuanced and thorough description of a research participant's life story and belief systems. | Behavioural | semi-structured interviews |
Primary outcome
psychosocial issues
Time frame: 2 years
related to lung cancer symptom recognition, delays in lung cancer diagnosis of Hispanic/Latino patients and treatment decision-making processes.
cultural issues
Time frame: 2 years
related to lung cancer symptom recognition, delays in lung cancer diagnosis of Hispanic/Latino patients and treatment decision-making processes.
1 secondary outcome
identify obstacles
Time frame: 2 years
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 11 Feb 2016.
- 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.
William Alago, MD 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 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 4 inclusion and 1 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 11 Feb 2016. 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?
psychosocial issues (time frame: 2 years). The study lists 2 primary outcomes in all. 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 11 Feb 2016.