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

Lung Carcinoma Clinical Trial

— AIRTECH  

Official title:

Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783168
• Other study ID #: 2020-0453
• Secondary ID: NCI-2020-1412620
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Garrett L Walsh
• Phone: 713-792-6849
• Email: gwalsh[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Carcinoma
• Lung Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Health Promotion and Education
Install and use Fitbit app
• Medical Device Usage and Evaluation
Use Fitbit to monitor step count
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 30 days after surgery
Secondary	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
Secondary	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
Secondary	Hospital length of stay		Up to 30 days after surgery
Secondary	Hospital readmission rate for lung surgery related events		Up to 30 days after surgery
Secondary	Return of bowel function	Time to first bowel movement.	Up to 30 days after surgery
Secondary	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
Secondary	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

External Links

•   MD Anderson Cancer Center Website