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

Study Overview
=================
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.

Official Title
-----------------
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study

Conditions
-----------------
Lung Carcinoma

Intervention / Treatment
-----------------
* Other: Best Practice
* Other: Health Promotion and Education
* Other: Medical Device Usage and Evaluation
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>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<br>* Receive usual care<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (usual care, Fitbit)<br>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<br>* Receive usual care<br>* Other names: standard therapy;Other: Medical Device Usage and Evaluation<br>* Use Fitbit to monitor step count<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm III (usual care, Fitbit, Fitbit app)<br>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<br>* Receive usual care<br>* Other names: standard therapy;Other: Health Promotion and Education<br>* Install and use Fitbit app<br>Other: Medical Device Usage and Evaluation<br>* Use Fitbit to monitor step count<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 30 days after surgery | 
| 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. | Baseline to 30 days after surgery | 
| Hospital length of stay |  | Up to 30 days after surgery | 
| Hospital readmission rate for lung surgery related events |  | Up to 30 days after surgery | 
| Return of bowel function | Time to first bowel movement. | Up to 30 days after surgery | 
| 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. | Up to 30 days after surgery | 
| 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. | Up to 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical, Wearable, device, fitness, tracker, Fitbit, ambulation, lung cancer, recovery