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

Primary Purpose

Lung Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Health Promotion and Education
Medical Device Usage and Evaluation
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Carcinoma focused on measuring Wearable, device, fitness, tracker, Fitbit, ambulation, lung cancer, surgical, recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Arm I (usual care)

Arm II (usual care, Fitbit)

Arm III (usual care, Fitbit, Fitbit app)

Arm Description

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 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

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.

Outcomes

Primary Outcome Measures

Clavien-Dindo postoperative morbidity (POM) score
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

Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])
Number of steps regained starting from after surgery for each of the arms.
Change in quality of life
Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.
Hospital length of stay
Hospital readmission rate for lung surgery related events
Return of bowel function
Time to first bowel movement.
Postoperative complications and step numbers
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.
Fitbit user experience (F0 and FB arm)
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.

Full Information

First Posted
February 3, 2021
Last Updated
April 19, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04783168
Brief Title
Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
Acronym
AIRTECH
Official Title
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma
Keywords
Wearable, device, fitness, tracker, Fitbit, ambulation, lung cancer, surgical, recovery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (usual care)
Arm Type
Active Comparator
Arm Description
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 Title
Arm II (usual care, Fitbit)
Arm Type
Active Comparator
Arm Description
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 Title
Arm III (usual care, Fitbit, Fitbit app)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive usual care
Intervention Type
Other
Intervention Name(s)
Health Promotion and Education
Intervention Description
Install and use Fitbit app
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Use Fitbit to monitor step count
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Clavien-Dindo postoperative morbidity (POM) score
Description
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.
Time Frame
Up to 30 days after surgery
Secondary Outcome Measure Information:
Title
Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])
Description
Number of steps regained starting from after surgery for each of the arms.
Time Frame
Up to 30 days after surgery
Title
Change in quality of life
Description
Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.
Time Frame
Baseline to 30 days after surgery
Title
Hospital length of stay
Time Frame
Up to 30 days after surgery
Title
Hospital readmission rate for lung surgery related events
Time Frame
Up to 30 days after surgery
Title
Return of bowel function
Description
Time to first bowel movement.
Time Frame
Up to 30 days after surgery
Title
Postoperative complications and step numbers
Description
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.
Time Frame
Up to 30 days after surgery
Title
Fitbit user experience (F0 and FB arm)
Description
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.
Time Frame
Up to 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older English speaking Ambulatory preoperatively 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: Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study. Cannot maintain activity monitor in place at the time of consent Pregnant patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garrett L Walsh
Phone
713-792-6849
Email
gwalsh@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garrett L Walsh
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett L. Walsh
Phone
713-792-6849
First Name & Middle Initial & Last Name & Degree
Garrett L. Walsh

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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