Lung Cancer SurvivorsNCT00586937
Quality of Life in Lung Cancer Survivors
An observational study of Lung Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out about the quality of life of individuals who have been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer Survivors
- What is being tested?
- questionnaires or telephone interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to 2 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Thoracic Surgery Database
Who may be able to join
- Diagnosis of primary Stage IA or IB NSCLC;
- Underwent surgical resection for NSCLC at MSKCC;
- From 1 to 5 years and 11 months post-treatment for NSCLC prior to study recruitment;
- No evidence of disease (NED) at the time of recruitment;
- Can be reached by telephone;
- Able to provide informed consent.
Who cannot join
- Undergoing active antineoplastic treatment;
- Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
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 find out about the quality of life of individuals who have been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. We are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. Learning about quality of life will help us to develop new services for lung cancer survivors.
- Conditions
- Lung Cancer Survivors
- Being tested
- questionnaires or telephone interview
- Keywords
- Lung Cancer Survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires or telephone interviewBehavioural
In the first phase, a random sample of lung cancer survivors will complete a comprehensive telephone interview or questionnaire by self-report focusing on assessment of quality of life and related covariates. We estimate the total time for completion of the survey by telephone interview or self-report to be 45-60 minutes. second phase of the study, a subset of telephone survey participants will take part in a focus group discussion that will explore their perceptions of barriers for delivery of post-treatment medical and psychosocial follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Lung Cancer Survivors Receives: Behavioral: questionnaires or telephone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the health-related quality of life (HQOL) of lung cancer survivors and compare their HQOL with age- and gender-appropriate, population-based normative data.
Measured: 2 years
Secondary outcomes (1)
To describe and identify covariates of HQOL in lung cancer survivors.
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 posted7 Jan 2008 (estimated)
- Study startJun 2005
- Primary completion2 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer SurvivorsStudies 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
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fox Chase Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586937
- Sponsor's protocol ID
- 05-057
- Status last verified
- Jan 2020
- First submitted
- 21 Dec 2007
- Last updated
- 6 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT00586937
- Acronym / sponsor ID
- 05-057
- Conditions
- Lung Cancer Survivors
- Keywords
- Lung Cancer Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Fox Chase Cancer Center
- Study start
- Jun 2005 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 7 Jan 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 find out about the quality of life of individuals who have been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. We are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. Learning about quality of life will help us to develop new services for lung cancer survivors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnaires or telephone interviewLung Cancer Survivors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thoracic Surgery Database
Key inclusion criteria (6 listed)
- Diagnosis of primary Stage IA or IB NSCLC;
- Underwent surgical resection for NSCLC at MSKCC;
- From 1 to 5 years and 11 months post-treatment for NSCLC prior to study recruitment;
- No evidence of disease (NED) at the time of recruitment;
- Can be reached by telephone;
Key exclusion criteria (2 listed)
- Undergoing active antineoplastic treatment;
- Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.
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 |
|---|---|---|
| questionnaires or telephone interviewIn the first phase, a random sample of lung cancer survivors will complete a comprehensive telephone interview or questionnaire by self-report focusing on assessment of quality of life and related covariates. We estimate the total time for completion of the survey by telephone interview or self-report to be 45-60 minutes. second phase of the study, a subset of telephone survey participants will take part in a focus group discussion that will explore their perceptions of barriers for delivery of post-treatment medical and psychosocial follow-up care. | Behavioural | 1 |
Primary outcome
To describe the health-related quality of life (HQOL) of lung cancer survivors and compare their HQOL with age- and gender-appropriate, population-based normative data.
Time frame: 2 years
1 secondary outcome
To describe and identify covariates of HQOL in lung cancer survivors.
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 6 Jan 2020.
- 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.
Jamie Ostroff, 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 Lung Cancer Survivors, 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 6 inclusion and 2 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 6 Jan 2020. 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 describe the health-related quality of life (HQOL) of lung cancer survivors and compare their HQOL with age- and gender-appropriate, population-based normative data. (time frame: 2 years). 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 6 Jan 2020.