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Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study (AIRTECH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04783168
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This clinical trial evaluates the relationship between walking and sleeping habits and surgical outcomes in patients with lung cancer. Early walking after surgery is associated with decreased or less severe complications. Learning about how much patients walk may be important in improving outcomes after surgery. Information gained from this trial may help researchers develop interventions to improve outcomes after surgery and improve overall quality of life after surgery in patients with lung cancer.

Condition or disease Intervention/treatment Phase
Lung Carcinoma Other: Best Practice Other: Health Promotion and Education Other: Medical Device Usage and Evaluation Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVE:

I. Estimate the difference between each Fitbit arm and a control arm in Clavien-Dindo Combined Postoperative Morbidity (POM) Score in the 30-day postoperative period.

SECONDARY OBJECTIVES:

I. For patients in Fitbit only arm (F0) and Fitbit integration arm (FB), evaluate the differences in steps regained at each postoperative day.

II. Quality of life before and after surgery using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC).

III. Hospital length of stay. IV. Hospital readmission rate within 30 days for lung surgery related events. V. Return of bowel function. VI. Postoperative complications and step numbers. VII. Fitbit user experience in the FB arm.

EXPLORATORY OBJECTIVES:

I. Sleep disturbances. II. Cost analysis.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.

ARM II: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count.

ARM III: Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.

After completion of study intervention, patients are followed up at postoperative clinic and at 30 days after surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I (usual care)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting.
 Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Active Comparator: Arm II (usual care, Fitbit)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and early ambulation in the postoperative setting. Patients also receive a Fitbit to monitor step count
 Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Medical Device Usage and Evaluation
Use Fitbit to monitor step count

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Experimental: Arm III (usual care, Fitbit, Fitbit app)
Patients receive usual care consisting of the clinician educating the patient on the importance of increasing exercise activity in the preoperative period and walking in the postoperative setting. Patients also receive a Fitbit device, install and use the Fitbit app on a smartphone. Postoperative step goals are as follows: Postoperative day (POD) 1: 25% of baseline. Subsequent days will be increased by 10% until patient reaches baseline daily step number. Five automatic daily reminders (delivered by the Fitbit Inspire HR^TM device itself) to meet a minimum of 250 steps an hour. Postoperatively, patients will be invited to participate in a private group with a leaderboard that consists of step numbers of other participants in the study in an anonymous fashion.
 Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Other: Health Promotion and Education
Install and use Fitbit app

Other: Medical Device Usage and Evaluation
Use Fitbit to monitor step count

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Clavien-Dindo postoperative morbidity (POM) score [ Time Frame: Up to 30 days after surgery ]

    Two Bayesian probability and inferential models will be utilized:

    • Model 1: Inferential goals: Probability that POM score in the control arm is greater than F0 or FB arm: mean and 95% Credible Interval

    • Model 2: Baseline covariates adjusted analysis of model 1

      • Performance status
      • FEV1
      • Age
      • Open vs. Minimally invasive (0 is best, 5 is worst.) 0 - No postoperative complications 1. - Minor complication resolved without intervention 2. - complication requiring pharmaceutical intervention 3. - complication requiring surgical, endoscopic or radiological intervention, 4. - life-threatening complication requiring intensive care 5. - complication leading to the patient's death.


Secondary Outcome Measures :
  1. Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB]) [ Time Frame: Up to 30 days after surgery ]
    Number of steps regained starting from after surgery for each of the arms.

  2. Change in quality of life [ Time Frame: Baseline to 30 days after surgery ]
    Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.

  3. Hospital length of stay [ Time Frame: Up to 30 days after surgery ]
  4. Hospital readmission rate for lung surgery related events [ Time Frame: Up to 30 days after surgery ]
  5. Return of bowel function [ Time Frame: Up to 30 days after surgery ]
    Time to first bowel movement.

  6. Postoperative complications and step numbers [ Time Frame: Up to 30 days after surgery ]
    How would you rate daily step goals as being helpful in your postoperative recovery? From 0-5, 0 being not helpful at all and 5 being the most helpful.

  7. Fitbit user experience (F0 and FB arm) [ Time Frame: Up to 30 days after surgery ]
    Survey. How would you rate the use of Fitbit in your postoperative recovery From 0-5, 0 being not helpful at all and 5 being the most helpful How difficult was it to keep the device on your wrist From 0-5, 0 being extremely difficult, and 5 being extremely easy.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • English speaking
  • Ambulatory preoperatively
  • Primary lung cancer
  • Patients undergoing at least a lobectomy
  • Must own a smart phone and be willing to install the Fitbit application (App)
  • Adequate internet connection via wifi or wireless network connection with smartphone
  • Patients who are not already using a wearable device to track daily steps

Exclusion Criteria:

  • Cannot maintain activity monitor in place at the time of consent
  • Pregnant patients
  • Pulmonary nodule from non-lung primary
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783168


Contacts
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Contact: Garrett L Walsh 713-792-6849 gwalsh@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Garrett L. Walsh    713-792-6849      
Principal Investigator: Garrett L. Walsh         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Garrett L Walsh M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04783168    
Other Study ID Numbers: 2020-0453
NCI-2020-14126 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0453 ( Other Identifier: M D Anderson Cancer Center )
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by M.D. Anderson Cancer Center:
Wearable
device
fitness
tracker
Fitbit
 ambulation
lung cancer
surgical
recovery
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases