Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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 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

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.

Best Practice

Health Promotion and Education

Medical Device Usage and Evaluation

Quality-of-Life Assessment

Questionnaire Administration

Garrett L Walsh

Garrett L. Walsh

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.

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.

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

Ambulation to Improve Recovery With Wearable TECHnology (AIRTECH) Study

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.

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

Assessed using MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC). (0 - 10 discrete numbers) 0 - Not present 10 - As bad as you can imagine.

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.

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.

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Urinary Bladder Neoplasms

Postoperative Complications

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Financial Incentive to Increase Ambulation: A financial reward is given on a per day basis when subject meets daily step goal, 1/5 chance to win additional monetary prize if patient uploads step count data for at least 75% of study days.

Subjects will use Fitbit Zip to track step counts

Subjects in this group will receive standard education on the benefits of post-surgery ambulation only Subjects will use Fitbit Zips to track step counts

Financial Incentive and possibility for financial lottery entry in addition to education on the benefits of post-surgery ambulation

Financial Incentive to Increase Ambulation

Gregory Tasian, MD,MSc,MSCE

Thomas Guzzo, MD, MPH

Radical cystectomy with urinary diversion is associated with substantial perioperative morbidity, including deep venous thrombosis, prolonged ileus, and postoperative functional decline. Post-operative morbidity after cystectomy prolongs the length of stay, increases the risk of readmission, and adds substantially to health care costs. Protocols that emphasize early and frequent ambulation after surgery decreases post-operative morbidity, but poor patient adherence diminishes the effectiveness of these protocols, which are currently implemented only during the hospital stay. Financial incentives overcome present bias and offer a novel and practical approach to increasing ambulation during the post-operative period in the hospital and also after discharge. This application proposes a pilot randomized, controlled trial to estimate the effect size of financial incentives on achieving a patient-specific daily step goal in the hospital and post-discharge for 1 month following radical cystectomy. Secondary outcomes include step count, composite morbidity, and functional decline. Forty-six adults with bladder cancer undergoing radical cystectomy at the Hospital of the University of Pennsylvania will be randomized to either control (education of step goal with monitoring and daily feedback) or a gain financial incentive combined with a lottery incentive if they achieve 75% of the daily goals during the study period. Fitbit Zips will be used to measure step counts for all participants. This proposal will provide the preliminary data needed to design future, larger trials that will test the effect of financial incentives to increase ambulation on post operative complications, readmissions, and functional decline.

In this application, a randomized controlled trial will be used to test the hypothesis that small financial incentives can be used to increase post-operative ambulation. The randomized controlled trial design is necessary to demonstrate a causal relationship between the intervention (provision of financial incentives)and the outcome (increased ambulation). This design will also provide preliminary data (e.g. effect sizes, feasibility) needed to design larger trials that will determine whether increases in ambulation produced by financial incentives can be translated into decreases in clinically relevant outcomes such as post-operative complications, readmissions, and functional decline in patients undergoing major abdominal surgery.

All participants will receive education about the importance of early ambulation and knowledge of their daily step goals. A Fitbit Zip, a commercially available activity tracking device with the ability to record and wirelessly upload step counts, will be provided to each participant to measure the outcome of daily step counts for a lead in period of 1-2 weeks before surgery and 30 days after surgery with the option for patients to continue to submit data independently for up to 90 days after surgery. The lead-in period will provide data to determine a patient-specific daily step count baseline. Step count goals will change each week and be determined by a set-percentage of the patient-specific baseline. The percentages will be as follows: 10% of baseline for week 1, 25% of baseline for week 2, 40% of baseline for week 3, and 55% of baseline for week 4. Data will be collected using the Way To Health platform, a digital platform specifically designed to facilitate randomized controlled trials testing interventions increase health promoting behavior.

Participants will be randomized using simple balanced randomization into one of two arms: "control" or "financial incentives". Individuals will be informed if they fail to achieve adequate steps and would have otherwise been eligible for payments in order to leverage regret aversion. The financial incentive is framed as a "gain" rather than a "loss" because striving to achieve a positive reward may provide the necessary support to positively motivate patients who just had major, painful surgery. Small definite payments are combined with larger lottery-based payments to provide ongoing feedback coupled with the possibility of winning a higher magnitude reward. Automated notification about payments will be delivered through the participant's preferred mode of communication (e.g., phone call, email). Patients will track their earnings and step count over time through Way to Health.

Beginning shortly before the planned surgery and continuing for 30 days after date of surgery, all participants will use Fitbit Zips to measure daily step counts. Patients will have the option of submitting up to 90 days of post-operative data. Post-operative ambulation has been repeatedly demonstrated to be beneficial to recovery by a number of different metrics, and the Zip device has been shown to be an accurate measure of step counts. The Stanford Health Assessment Questionnaire (SHAQ) is a broadly used and validated questionnaire which, in its shortened form, assesses subjects ability to perform 20 different actions and the need for assistance with these actions. It also captures patients global assessments of pain and well-being. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measured post-operative functional decline. The International Physical Activity Questionnaire (IPAQ) Short Seven Day form quantifies patient reported levels of physical activity over the seven days prior to the interview. It is similarly broadly used and has been previously validated against accelerometer data. This will be administered preoperatively, 30 days post-operatively, and 90 days postoperatively to measure post-operative decline in physical activity and to discover differences in baseline physical activity that are not captured by preoperative step-count data.The Multidimensional Scale of Perceived Social Support (MPPSS) is a validated tool for assessing patient's self-assessed degree of support from others. Prior research has suggested social support as an important factor in exercise behavior, which is consistent with our clinical observations. This will be administered pre-operatively and a 30 and 90 days post-operatively to help account for confounding by this important and otherwise unmeasured variable.

Steps to Eliminate Postoperative Problems

Number of days during the study period that each subject reaches their step goal

Average number of steps taken per day in the 30 day postoperative period. Note that the average number of steps taken per day is calculated separately for each patient as simply (total number of steps taken in the 30 day postoperative period)/30. For the purposes of comparing the two study groups, nonparametric tests and medians are used. Thus the "measure type" listed in the "Outcome Measure Data Table" is correctly listed as "median". For example, in the Financial Incentive arm, we report a median average number of steps per day as 979, implying that half of the patients walked fewer than 979 steps on an average day and half of the patients walked more than 979 steps on an average day in that group.

Binary variable reflecting whether or not patient suffered any of the following: any postoperative complication, any unplanned readmission, any presentation to the emergency department within 30 days after surgery.

30-day postoperative Stanford Health Assessment Questionnaire Disability Index (SHAQ) score, indicating subjects ability to perform daily tasks.

Scores range continuously from 0-4 representing no disability to complete disability respectively. Scores \>2 are usually considered severe disability.

The total score is computed as the mean of 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each category consists of a list of 2-3 actions. The participant selects whether they are able to perform each action "without any difficulty", "with some difficulty", "with much difficulty", or "unable to do". These selections are scored 0-4 respectively. The category is assigned the maximum score of its component actions. If the subject requires assistance from a person or device for an individual action, the minimum score for that action is 2.

Children's Hospital of Philadelphia

National Center for Advancing Translational Sciences (NCATS)

University of Pennsylvania

Financial Incentive

Control (Education)

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Dr. Marshall Strother

Number of Days Step Goal Completed

Number of Steps Taken Per Day

Protocol revised to remove this outcome. No data collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Walking After Surgery to Improve Recovery and Outcomes After Surgery, AIRTECH Study	NCT04783168	Lung Carcinoma	Best Practice Health Promotio... Medical Device ... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Steps to Eliminate Postoperative Problems	NCT02880176	Bladder Cancer	Financial Incen...	21 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for ambulation

Every month we try and update this database with for ambulation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ambulation

Every month we try and update this database with for ambulation cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ambulation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.