Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
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.
Arms & interventions
- OtherBest Practice
Receive usual care
- OtherHealth Promotion and Education
Install and use Fitbit app
- OtherMedical Device Usage and Evaluation
Use Fitbit to monitor step count
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
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.
Time frame: Up to 30 days after surgery
Secondary
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
Change in quality of life
Time frame: Baseline to 30 days after surgery
Hospital length of stay
Time frame: Up to 30 days after surgery
Hospital readmission rate for lung surgery related events
Time frame: Up to 30 days after surgery
Return of bowel function
Time frame: Up to 30 days after surgery
Postoperative complications and step numbers
Time frame: Up to 30 days after surgery
Fitbit user experience (F0 and FB arm)
Time frame: Up to 30 days after surgery
Eligibility criteria
Study locations (1)
M D Anderson Cancer Center
Houston, Texas, 77030