Recruiting

Walking

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04783168

Conditions

Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Health Promotion and Education

Medical Device Usage and Evaluation

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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.

Conditions

Lung Carcinoma

Study ID

NCT04783168

Start date

Nov 30, 2020

Status verified date

Apr, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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

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.

Interventions

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

Primary outcome measure

  • Clavien-Dindo postoperative morbidity (POM) score [ Time Frame: Up to 30 days after surgery ]

Central Contacts and Locations

Central contacts

Garrett L Walsh

713-792-6849gwalsh@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Garrett L. Walsh

713-792-6849

Principal Investigator:

Garrett L. Walsh

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Wearable
  • device
  • fitness
  • tracker
  • Fitbit
  • ambulation
  • lung cancer
  • surgical
  • recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-16.