Lung CancerNCT00717795
Physical Activity Intervention for Lung Cancer Survivors
An observational study of Lung Cancer and Survivor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer, Survivor
- What is being tested?
- interview and physical activity and interview and wait list
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2008to 5 Jun 2023
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In total, we will recruit and enroll a random sample of 70 lung cancer survivors who are at least one year post thoracic surgical resection and have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any adjuvant treatment.
Who may be able to join
- Diagnosis and treatment at MSKCC of primary NSCLC; and/or pulmonary carcinoid;
- At least one year post thoracic surgical resection;
- Have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any cancer treatment;
- Currently sedentary or insufficiently active, defined by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention as less than a total of 150 minutes of at least moderate intensity PA per week;
- Able to complete a six-minute walk test (6MWT);
- Able to provide informed consent.
- FOCUS GROUP ONLY:
- Completed the Physical Activity program offered through this study (08067);
Who cannot join
- Presence of one of the following medical factors at screening:
- regular use of an ambulatory aid (cane or walker);
- resting oxygen saturation less than 88%;
- inability to walk due to severe arthritis or other musculoskeletal problems;
- a diagnosis of unstable angina in the previous 6 weeks;
- a heart attack, angioplasty or heart surgery in the previous 3 months;
Show all 13Show fewer
- current heart rate <50 or >120 at rest; current uncontrolled hypertension;
- current significant valvular heart disease or decompensated congestive heart failure and
- patient reported pain of any origin that would preclude participation in the proposed PA intervention
- Evidence of significant medical cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention
- Self-reporting of greater than 60 minutes of vigorous activity per week or 150 minutes of moderate intensity PA per week.
- Patient resides at more than two hours travel distance from the Center
- Insufficient English fluency to complete evaluation tools.
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 learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors.
- Conditions
- Lung Cancer, Survivor
- Being tested
- interview and physical activity, interview and wait list
- Keywords
- Survivor, Physical Activity, NED, 08-067
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interview and physical activityBehavioural
For Arm 1 participants in the Physical Activity intervention condition will be assessed at baseline, and postintervention Follow-up (at 12 weeks post baseline).
interview and wait listBehavioural
Participants in the control condition (Arm 2)will be assessed at baseline and 12 weeks post baseline (Follow-up). At this time, the PA intervention will be offered at no cost to the participants in the control condition. If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Arm 1 - Physical Activity intervention Receives: Behavioral: interview and physical activity | |
| 2 | Arm 2 - Wait-list control Receives: Behavioral: interview and wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility (acceptability, adherence, treatment integrity, retention, participant satisfaction) of implementing a physical activity intervention trial among sedentary and insufficiently active lung cancer survivors.
Measured: conclusion of the study
Secondary outcomes (2)
Obtain preliminary data on effect of a physical activity intervention on functional ability, health-related QOL, dyspnea, fatigue, balance, strength & self-report physical activity among sedentary and insufficiently active lung cancer survivors
Measured: conclusion of the study
To obtain preliminary data on factors associated with feasibility using variables from Social Cognitive Theory and assess their relationship with treatment adherence and dropout.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study start10 Jun 2008
- Primary completion5 Jun 2023
- Study completion5 Jun 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fox Chase Cancer Center, University of Alberta, Brown University
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717795
- Sponsor's protocol ID
- 08-067
- Status last verified
- Jun 2023
- First submitted
- 16 Jul 2008
- Last updated
- 7 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Intervention for Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT00717795
- Acronym / sponsor ID
- 08-067
- Conditions
- Lung Cancer, Survivor
- Keywords
- Survivor, Physical Activity, NED, 08-067
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Fox Chase Cancer Center, University of Alberta, Brown University
- Study start
- 10 Jun 2008 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 18 Jul 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 learn how many lung cancer survivors will agree to a physical activity program. We also want to know if lung cancer survivors benefit from this program. This information will help us to develop our services for lung cancer survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: interview and physical activityArm 1 - Physical Activity intervention |
| 2 | – | Behavioral: interview and wait listArm 2 - Wait-list control |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In total, we will recruit and enroll a random sample of 70 lung cancer survivors who are at least one year post thoracic surgical resection and have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any adjuvant treatment.
Key inclusion criteria (8 listed)
- Diagnosis and treatment at MSKCC of primary NSCLC; and/or pulmonary carcinoid;
- At least one year post thoracic surgical resection;
- Have no evidence of NSCLC or any other cancer at the time of study enrollment and not receiving any cancer treatment;
- Currently sedentary or insufficiently active, defined by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention as less than a total of 150 minutes of at least moderate intensity PA per week;
- Able to complete a six-minute walk test (6MWT);
Key exclusion criteria (13 listed)
- Presence of one of the following medical factors at screening:
- Evidence of significant medical cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in the intervention
- Self-reporting of greater than 60 minutes of vigorous activity per week or 150 minutes of moderate intensity PA per week.
- Patient resides at more than two hours travel distance from the Center
- Insufficient English fluency to complete evaluation tools.
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 |
|---|---|---|
| interview and physical activityFor Arm 1 participants in the Physical Activity intervention condition will be assessed at baseline, and postintervention Follow-up (at 12 weeks post baseline). | Behavioural | 1 |
| interview and wait listParticipants in the control condition (Arm 2)will be assessed at baseline and 12 weeks post baseline (Follow-up). At this time, the PA intervention will be offered at no cost to the participants in the control condition. If the waitlist participant chooses to complete the PA intervention after the 12 week waitlist period, program satisfaction will be assessed after study completion. | Behavioural | 2 |
Primary outcome
To evaluate the feasibility (acceptability, adherence, treatment integrity, retention, participant satisfaction) of implementing a physical activity intervention trial among sedentary and insufficiently active lung cancer survivors.
Time frame: conclusion of the study
2 secondary outcomes
Obtain preliminary data on effect of a physical activity intervention on functional ability, health-related QOL, dyspnea, fatigue, balance, strength & self-report physical activity among sedentary and insufficiently active lung cancer survivors
Time frame: conclusion of the study
To obtain preliminary data on factors associated with feasibility using variables from Social Cognitive Theory and assess their relationship with treatment adherence and dropout.
Time frame: conclusion of the 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 7 Jun 2023.
- 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 and Survivor, 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 8 inclusion and 13 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 7 Jun 2023. 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 evaluate the feasibility (acceptability, adherence, treatment integrity, retention, participant satisfaction) of implementing a physical activity intervention trial among sedentary and insufficiently active lung cancer survivors. (time frame: conclusion of the 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 7 Jun 2023.