Clinical trial NCT04783168: Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
Official title: Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Keywords: Wearable
device
fitness
tracker
Fitbit
ambulation
lung cancer
surgical
recovery
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Clavien-Dindo postoperative morbidity (POM) score
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB])
timeFrame: Up to 30 days after surgery
measure: Change in quality of life
timeFrame: Baseline to 30 days after surgery
measure: Hospital length of stay
timeFrame: Up to 30 days after surgery
measure: Hospital readmission rate for lung surgery related events
timeFrame: Up to 30 days after surgery
measure: Return of bowel function
timeFrame: Up to 30 days after surgery
measure: Postoperative complications and step numbers
timeFrame: Up to 30 days after surgery
measure: Fitbit user experience (F0 and FB arm)
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Garrett L Walsh
role: PRINCIPAL_INVESTIGATOR
References: