ClinicalTrials.Veeva

Menu

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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Lung Carcinoma

Treatments

Other: Medical Device Usage and Evaluation
Other: Best Practice
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Other: Health Promotion and Education

Study type

Interventional

Funder types

Other

Identifiers

NCT04783168
2020-0453 (Other Identifier)
NCI-2020-14126 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 3 patient groups

Arm I (usual care)
Active Comparator group
Description:
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.
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Best Practice
Arm II (usual care, Fitbit)
Active Comparator group
Description:
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
Treatment:
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Best Practice
Other: Medical Device Usage and Evaluation
Arm III (usual care, Fitbit, Fitbit app)
Experimental group
Description:
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.
Treatment:
Other: Health Promotion and Education
Other: Questionnaire Administration
Other: Quality-of-Life Assessment
Other: Best Practice
Other: Medical Device Usage and Evaluation

Trial contacts and locations

1

Loading...

Central trial contact

Garrett L Walsh

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems