Lung CancerNCT02755883
Strides for Life I: Increasing Physical Activity in Stage 1 Lung Cancer Patients
A study testing Physical activity plus positive affect and Physical activity plus education in people with Lung Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational Control group results in improved function at 6-months. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Physical activity plus positive affect and Physical activity plus education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2017
- Phase
- Interventional
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-small cell lung cancer (Stage 1)
Who cannot join
- Cognitive impairment
- Inability to walk
- < 12 month anticipated survival
- enrollment in other behavioral programs
- lack of medical approval to participate
- substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
- major psychiatric illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: Strides For Life I: A Randomized Controlled Trial of Induction of Positive Affect to Increase Physical Activity in Early Stage Lung Cancer Survivors
This randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational Control group results in improved function at 6-months.
Read the detailed description
This is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small cell lung cancer patients, whether induction of positive affect vs. an educational Control group, results in improved function as assessed by the 6-minute Walk Test. Our primary outcome will be a within-patient change in the 6-Minute Walk Test at 6 months.
- Conditions
- Lung Cancer
- Being tested
- Physical activity plus positive affect, Physical activity plus education
- Keywords
- Physical activity, non-small lung cancer, positive affect
- 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.
Physical activity plus positive affectBehavioural
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
Physical activity plus educationBehavioural
Subjects will be randomized to a physical activity goal and will receive the educational component.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity plus positive affect | Experimental | Subjects will be randomized to a physical activity goal and the positive affect component Receives: Behavioral: Physical activity plus positive affect |
| Physical activity plus education | Active comparator | Subjects will be randomized to a physical activity goal and education Receives: Behavioral: Physical activity plus education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kilocalories/week assessed by 6-minute walk test
Measured: 1 month to 6 months
Secondary outcomes (4)
Forced expiratory volume (FEV1)
Pulmonary function test
Measured: 1 month to 6 months
Functional Assessment of Cancer Therapy- Lung (FACT-L14)
Disease-specific quality of life
Measured: 1 month to 6 months
Activity expenditure (assessed by the Fit Bit Zip accelerometer)
Measured: 1 month to 6 months
Maximal Oxygen Consumption (VO2 max)
Pulmonary function test
Measured: 1 month to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017
- Study completionOct 2017
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Lung Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Janey Peterson, EdD, MS, RN, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755883
- Sponsor's protocol ID
- 1510016644
- Status last verified
- Feb 2018
- First submitted
- 25 Apr 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strides For Life I: A Randomized Controlled Trial of Induction of Positive Affect to Increase Physical Activity in Early Stage Lung Cancer Survivors
- ClinicalTrials.gov ID
- NCT02755883
- Acronym / sponsor ID
- 1510016644
- Conditions
- Lung Cancer
- Keywords
- Physical activity, non-small lung cancer, positive affect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Lung Cancer Research Foundation
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Apr 2016 (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.
This randomized controlled trial will evaluate, among 54 stage early stage lung cancer patients, whether a behavioral intervention versus an educational Control group results in improved function at 6-months.
Detailed description
This is a two arm randomized controlled trial that will evaluate, among 54 stage 1 non-small cell lung cancer patients, whether induction of positive affect vs. an educational Control group, results in improved function as assessed by the 6-minute Walk Test. Our primary outcome will be a within-patient change in the 6-Minute Walk Test at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity plus positive affect | Experimental | Behavioral: Physical activity plus positive affectSubjects will be randomized to a physical activity goal and the positive affect component |
| Physical activity plus education | Active comparator | Behavioral: Physical activity plus educationSubjects will be randomized to a physical activity goal and education |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-small cell lung cancer (Stage 1)
Key exclusion criteria (7 listed)
- Cognitive impairment
- Inability to walk
- < 12 month anticipated survival
- enrollment in other behavioral programs
- lack of medical approval to participate
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 |
|---|---|---|
| Physical activity plus positive affectSubjects will be randomized to a physical activity goal and will receive the positive affect component. | Behavioural | Physical activity plus positive affect |
| Physical activity plus educationSubjects will be randomized to a physical activity goal and will receive the educational component. | Behavioural | Physical activity plus education |
Primary outcome
Kilocalories/week assessed by 6-minute walk test
Time frame: 1 month to 6 months
4 secondary outcomes
Forced expiratory volume (FEV1)
Time frame: 1 month to 6 months
Functional Assessment of Cancer Therapy- Lung (FACT-L14)
Time frame: 1 month to 6 months
Activity expenditure (assessed by the Fit Bit Zip accelerometer)
Time frame: 1 month to 6 months
Maximal Oxygen Consumption (VO2 max)
Time frame: 1 month to 6 months
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 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Janey Peterson, EdD, MS, RN principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity plus positive affect and Physical activity plus education in people with Lung Cancer, run by Weill Medical College of Cornell University 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 1 inclusion and 7 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 Feb 2018. 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?
Kilocalories/week assessed by 6-minute walk test (time frame: 1 month to 6 months). 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 Feb 2018.