M D Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT04783168
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive usual care
Other names: standard of care, standard therapy
Install and use Fitbit app
Use Fitbit to monitor step count
Ancillary studies
Other names: Quality of Life Assessment
Ancillary studies
Time frame: Up to 30 days after surgery
Two Bayesian probability and inferential models will be utilized:
Time frame: Up to 30 days after surgery
Number of steps regained starting from after surgery for each of the arms.
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.
Time frame: Up to 30 days after surgery
Time frame: Up to 30 days after surgery
Time frame: Up to 30 days after surgery
Time to first bowel movement.
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.
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.
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Acronym: AIRTECH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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