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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Garrett L. Walsh
713-792-6849

More Details

NCT ID
NCT04783168
Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Garrett L Walsh
713-792-6849
gwalsh@mdanderson.org

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center