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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04783168
Collaborator
(none)
240
1
3
17
14.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Health Promotion and Education
  • Other: Medical Device Usage and Evaluation
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. For patients in Fitbit only arm (F0) and Fitbit integration arm (FB), evaluate the differences in steps regained at each postoperative day.

  2. Quality of life before and after surgery using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC).

  3. 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:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study
Actual Study Start Date :
Nov 30, 2020
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (usual care)

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.

Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Active Comparator: Arm II (usual care, Fitbit)

    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

    Other: Best Practice
    Receive usual care
    Other Names:
  • standard of care
  • standard therapy
  • Other: Medical Device Usage and Evaluation
    Use Fitbit to monitor step count

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Experimental: Arm III (usual care, Fitbit, Fitbit app)

    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.

    Other: Best Practice
    Receive usual care
    Other Names:
  • standard of care
  • standard therapy
  • Other: Health Promotion and Education
    Install and use Fitbit app

    Other: Medical Device Usage and Evaluation
    Use Fitbit to monitor step count

    Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Clavien-Dindo postoperative morbidity (POM) score [Up to 30 days after surgery]

      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.

    Secondary Outcome Measures

    1. Differences in steps regained at each postoperative day (Fitbit only arm [F0] and Fitbit integration arm [FB]) [Up to 30 days after surgery]

      Number of steps regained starting from after surgery for each of the arms.

    2. Change in quality of life [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.

    3. Hospital length of stay [Up to 30 days after surgery]

    4. Hospital readmission rate for lung surgery related events [Up to 30 days after surgery]

    5. Return of bowel function [Up to 30 days after surgery]

      Time to first bowel movement.

    6. Postoperative complications and step numbers [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.

    7. Fitbit user experience (F0 and FB arm) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18 years or older

    • English speaking

    • Ambulatory preoperatively

    • Primary lung cancer

    • 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:
    • Cannot maintain activity monitor in place at the time of consent

    • Pregnant patients

    • Pulmonary nodule from non-lung primary

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Garrett L Walsh, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04783168
    Other Study ID Numbers:
    • 2020-0453
    • NCI-2020-14126
    • 2020-0453
    First Posted:
    Mar 5, 2021
    Last Update Posted:
    Mar 16, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 16, 2021