Lung Neoplasm MalignantNCT03352245
Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer
A study testing Prescribed Activity in people with Lung Neoplasm Malignant, run by Yale University at 1 site in United States.
Trial summary
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Prescribed Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 24 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
- Approval of the treating clinician
- Adult patients (age >21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA)
- Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
- Low activity level as judged by a brief physical activity questionnaire (i.e., <150 minutes/week of moderate-intensity exercise, <75 minutes/week of vigorous aerobic exercise, or an equivalent combination).
Who cannot join
- Memory impairment (as judged by the treating clinician)
- Communication impairment (as judged by the treating clinician)
- Treating clinician's request not to alter physical activity
- Physical inability to safely walk (as judged by the treating clinician)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Prescribed Activity
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescribed ActivityBehavioural
Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Prescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2). Receives: Behavioral: Prescribed Activity |
| Control Group | No intervention | Usual care group will receive standard of care management from their Oncologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Step Count
Participants will wear a Fitbit wrist band that will record step count.
Measured: baseline to 12 weeks
Number of Weeks Participants Adhered to Step Count Recommendations
Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of "usable" weeks). A week is considered "usable" if 5/7 days of step counts are available, and days with <200 steps/day are considered not usable.
Measured: baseline to 12 weeks.
Secondary outcomes (24)
Dyspnea
Assessed via self-report using the Modified Medical Research Council. Dyspnea Scale, a single-item scale scored 0-4; higher score indicates worse dyspnea.
Measured: change from pre- to post-intervention (week 12)
Depression
Assessed via self-report using the Patient Health Questionnaire, Depression Module (PHQ-9). a 9-item questionnaire that assesses depressive symptoms over the preceding two weeks. Each item is scored 0-3 (0 = "Not at all"; 1 = "Several days"; 2 = "More than half of days"; 3 = "Nearly every day"). A total score is calculated by taking the sum of questions 1-9, and a higher score indicates worse depression.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Global Health Status
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales:
Global health status/Quality of Life (QoL) scale, range 0-100, higher score = better quality of life.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Physical Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measure physical functioning.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Role Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures role functioning.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Emotional Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures emotional functioning.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Fatigue
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures fatigue.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Cognitive Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures cognitive functioning.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Nausea/Vomiting
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures nausea and vomiting The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Pain
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the symptom scale measures pain.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Social Functioning
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the 5 functional scales measures social functioning.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Dyspnea
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure dyspnea.
The range of score is 0-100; higher score = higher symptoms burden.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Insomnia
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure insomnia.
The range of score is 0-100; higher score = better functioning.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Appetite Loss
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure appetite loss The range of score is 0-100; higher score = higher symptoms burden.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Constipation
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure constipation.
The range of score is 0-100; higher score = higher symptoms burden.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Diarrhea
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure diarrhea.
The range of score is 0-100; higher score = higher symptoms burden.
Measured: change from pre- to post-intervention (week 12)
Change in Quality of Life: Financial Difficulties
Assessed via self-report using the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire (QLQ-C30, Version 3). The scale measures quality of life in 30 questions with 15 subscales. One of the scales measure financial difficulties.
The range of score is 0-100; higher score = higher symptoms burden.
Measured: change from pre- to post-intervention (week 12)
Moderate Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Measured: baseline to 12 weeks
Vigorous Aerobic Exercise
The investigators will use the Physical Activity Questionnaire that measures this outcome in minutes.
Measured: baseline to 12 weeks
Change in C-reactive Protein (CRP)
The investigators will obtain serum CRP, a marker of inflammation.
Measured: change from pre- to post-intervention (week 12)
Change in Leptin Level
The investigators will obtain serum leptin, a marker of glucose control. .
Measured: change from pre- to post-intervention (week 12)
Change in Insulin Level
The investigators will obtain serum insulin level, a measure of glucose control.
Measured: change from pre- to post-intervention (week 12)
Programmed Death - Ligand
The investigators will collect soluble PD- L1, a novel cancer marker.
Measured: change from pre- to post-intervention (week 12)
Programmed Cell Death (PD-1)
The investigators will collect soluble PD- 1, a novel cancer marker.
Measured: change from pre- to post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start26 Nov 2018
- Primary completion24 May 2020
- Study completion24 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, VA Connecticut Healthcare System, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brett Bade, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352245
- Sponsor's protocol ID
- 2000022225
- Other IDs
- 1P50CA196530-01
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2017
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bade BC, Gan G, Li F, Lu L, Tanoue L, Silvestri GA, Irwin ML. "Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". BMC Cancer. 2021 Apr 1;21(1):352. doi: 10.1186/s12885-021-08084-0.
PubMed 33794808
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of a Patient-centered Activity Regimen in Patients With Advanced Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT03352245
- Acronym / sponsor ID
- 2000022225
- Conditions
- Lung Neoplasm Malignant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, VA Connecticut Healthcare System, National Cancer Institute (NCI)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 24 May 2020 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of >50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Prescribed ActivityPrescribed Activity designed to improve patient participation and adherence to prescriptions to increase physical activity and will include: (1) an educational session at enrollment, (2) subject communication via tailored electronic messaging, and (3) a wrist-bound device (FitBit Flex 2). |
| Control Group | No intervention | –Usual care group will receive standard of care management from their Oncologist. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
- Approval of the treating clinician
- Adult patients (age >21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA)
- Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
- Low activity level as judged by a brief physical activity questionnaire (i.e., <150 minutes/week of moderate-intensity exercise, <75 minutes/week of vigorous aerobic exercise, or an equivalent combination).
Key exclusion criteria (4 listed)
- Memory impairment (as judged by the treating clinician)
- Communication impairment (as judged by the treating clinician)
- Treating clinician's request not to alter physical activity
- Physical inability to safely walk (as judged by the treating clinician)
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 |
|---|---|---|
| Prescribed ActivityEducational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2) | Behavioural | Intervention Group |
Primary outcome
Overall Step Count
Time frame: baseline to 12 weeks
Participants will wear a Fitbit wrist band that will record step count.
Number of Weeks Participants Adhered to Step Count Recommendations
Time frame: baseline to 12 weeks.
Exercise Adherence will be defined as (the number of weeks a subject follows the activity prescription)/(the number of "usable" weeks). A week is considered "usable" if 5/7 days of step counts are available, and days with <200 steps/day are considered not usable.
24 secondary outcomes
Dyspnea
Time frame: change from pre- to post-intervention (week 12)
Depression
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Global Health Status
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Physical Functioning
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Role Functioning
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Emotional Functioning
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Fatigue
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Cognitive Functioning
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Nausea/Vomiting
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Pain
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Social Functioning
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Dyspnea
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Insomnia
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Appetite Loss
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Constipation
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Diarrhea
Time frame: change from pre- to post-intervention (week 12)
Change in Quality of Life: Financial Difficulties
Time frame: change from pre- to post-intervention (week 12)
Moderate Aerobic Exercise
Time frame: baseline to 12 weeks
Vigorous Aerobic Exercise
Time frame: baseline to 12 weeks
Change in C-reactive Protein (CRP)
Time frame: change from pre- to post-intervention (week 12)
Change in Leptin Level
Time frame: change from pre- to post-intervention (week 12)
Change in Insulin Level
Time frame: change from pre- to post-intervention (week 12)
Programmed Death - Ligand
Time frame: change from pre- to post-intervention (week 12)
Programmed Cell Death (PD-1)
Time frame: change from pre- to post-intervention (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33794808Bade BC, Gan G, Li F, Lu L, Tanoue L, Silvestri GA, Irwin ML. "Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study". BMC Cancer. 2021 Apr 1;21(1):352. doi: 10.1186/s12885-021-08084-0.
- Individual participant dataSharing planned: No
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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.
Brett Bade, M.D. principal investigator
Yale 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 Prescribed Activity in people with Lung Neoplasm Malignant, run by Yale 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 5 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 15 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Step Count (time frame: baseline to 12 weeks). 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?
On the ClinicalTrials.gov record for NCT03352245, which also lists 1 linked publication.
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 15 Feb 2024.