Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study
ConditionLung Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
English speaking
Ambulatory preoperatively
Patients undergoing at least a lobectomy
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive usual care
Health Promotion and Education
Other interventionInstall and use Fitbit app
Medical Device Usage and Evaluation
Other interventionUse Fitbit to monitor step count
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Arm I (usual care)Active comparator 3 interventions
Group B: Arm II (usual care, Fitbit)Active comparator 4 interventions
Group C: Arm III (usual care, Fitbit, Fitbit app)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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.
Time frame
Up to 30 days after surgery2
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.
Time frame
Baseline to 30 days after surgery3
Hospital length of stay
Time frame
Up to 30 days after surgery4
Hospital readmission rate for lung surgery related events
Time frame
Up to 30 days after surgerySponsors and contacts
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Source ClinicalTrials.gov