Malignant Neoplasm
Conditions
Brief summary
This trial studies the impact of early mobility tracked with a 3-dimensional (3D) motion tracking technology (XSENS) on post-surgery recovery in patients undergoing oncologic surgeries. Xsens uses wireless measurements which could be used in clinical settings to objectively measure movement patterns (the joint range of movement and the distance of movement) during functional activities. Post-surgery mobility tracking may help doctors to identify the minimum required level of mobility after inpatient oncologic surgeries to enhance early post-surgery recovery and decrease early post-surgery complications.
Detailed description
PRIMARY OBJECTIVES: I. To investigate objectively using evidence based randomized controlled trial the impact of early mobility (first day after the surgery) after any inpatient oncologic procedures on early recovery of postoperative course. II. Try to find out the minimum level of postoperative mobility that needed for early postoperative course recovery by objective assessment of range of movement for each participant using 3D motion tracking system (Xsens). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. ARM II: Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. After completion of study, patients are followed up for 30 days post discharge.
Interventions
OTHERBest Practice
Receive standard of care
OTHERPhysical Activity
Walk for minimum 30 minutes per day
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulant inpatient with a stay of \>= 2 days after any inpatient oncologic surgery * Eastern Cooperative Oncology Group (ECOG) scale of performance status of less than 3 * American Society of Anesthesiologist score (ASA) 3 or less * Participants who do not engage in regular exercise regimen before the surgery (other than regular occupational physical therapy) * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion criteria
* Patients with altered mental status * Patients with psychiatric illness * ECOG scale performance status 3 or more * ASA score of 4 * Participants who engage in regular exercise regimen before surgery (at least one session per week) * Patients with restricted movement due to other diseases * Patients who require continuous monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or Absence of Chest Symptoms | Up to 30 days after discharge | Presence or absence of chest symptoms (cough, sputum, and ability of using incentive spirometry), treated as a binary variable |
| Early Discharge From the Hospital | Up to 30 days after discharge | Days from operation until hospital discharge, treated as continuous variable |
| Surgical Related Complications and Readmissions | Up to 30 days after discharge | Presence or absence of surgical complication (including readmission), treated as a binary variable |
| Changes in Mobility | Baseline up to 30 days post discharge | changes in mobility (as measured by average velocity of pelvis) from baseline to discharge are compared between groups using a one-sided, two-sample t-test. |
| Early Return of Bowel Motion | Up to 30 days after discharge | Days from operation to passing flatus and/or stool, treated as continuous measure |
| Presence or Absence of Nausea and/or Vomiting | Up to 30 days after discharge | Presence or absence of nausea and/or vomiting, treated as a binary variable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical Complications | Up to 30 days post discharge | The complication status (present/absent) and grades will be summarized by group and compared using Fisher's exact test or the chi-square test, as appropriate. |
| Change in Exercise Habits Outside of the Hospital | Up to 3 months post discharge | Post study questionnaire . |
| Application of Sensors in a Hospital Setting | Up to 3 months post discharge | Adequate application of sensors, treated as a categorical variable |
| Mobility Quality of Life Questionnaire | Up to 3 months post discharge | The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire. |
| Range of Joint Movement in Upper and Lower Joints of Body | Up to 30 days after discharge | Will be measured using the 3 dimensional (3D) motion tracking system (Xsens), to identify the minimum required level of mobility for better early postoperative course recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Usual Care) Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.
Best Practice: Receive standard of care
Questionnaire Administration: Ancillary studies | 5 |
| Arm II (Additional Mobility) Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.
Physical Activity: Walk for minimum 30 minutes per day
Questionnaire Administration: Ancillary studies | 12 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Arm I (Usual Care) | Arm II (Additional Mobility) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 63.2 years STANDARD_DEVIATION 5.8 | 67.7 years STANDARD_DEVIATION 8.4 | 66.2 years STANDARD_DEVIATION 7.8 |
| Godin Score | 21.3 units on a scale STANDARD_DEVIATION 9 | 21.4 units on a scale STANDARD_DEVIATION 12 | 21.3 units on a scale STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 5 participants | 12 participants | 17 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 12 |
| other Total, other adverse events | 0 / 5 | 0 / 12 |
| serious Total, serious adverse events | 0 / 5 | 0 / 12 |
Outcome results
Primary
Changes in Mobility
changes in mobility (as measured by average velocity of pelvis) from baseline to discharge are compared between groups using a one-sided, two-sample t-test.
Time frame: Baseline up to 30 days post discharge
Population: One patient (arm 2) removed consent prior to treatment initiation and outcome recording.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Usual Care) | Changes in Mobility | 0.16 m/s | Standard Deviation 0.15 |
| Arm II (Additional Mobility) | Changes in Mobility | 0.58 m/s | Standard Deviation 2.1 |
Comparison: The null hypothesis is that the mean change is equal between the groups, while the alternative is that an increased difference is observed in arm 2. The hypotheses are evaluated using a one-sided, two-sample t-test.p-value: 0.329t-test, 1 sided
Primary
Early Discharge From the Hospital
Days from operation until hospital discharge, treated as continuous variable
Time frame: Up to 30 days after discharge
Population: One patient (arm II) removed consent prior to treatment initiation and outcome recording.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Usual Care) | Early Discharge From the Hospital | 2.0 days | Standard Deviation 1.2 |
| Arm II (Additional Mobility) | Early Discharge From the Hospital | 3.5 days | Standard Deviation 2.8 |
Primary
Early Return of Bowel Motion
Days from operation to passing flatus and/or stool, treated as continuous measure
Time frame: Up to 30 days after discharge
Population: One patient (arm 2) removed consent prior to treatment initiation and outcome recording.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Usual Care) | Early Return of Bowel Motion | 0.80 days | Standard Deviation 0.45 |
| Arm II (Additional Mobility) | Early Return of Bowel Motion | 0.90 days | Standard Deviation 0.32 |
Primary
Presence or Absence of Chest Symptoms
Presence or absence of chest symptoms (cough, sputum, and ability of using incentive spirometry), treated as a binary variable
Time frame: Up to 30 days after discharge
Population: Variable was not recorded.
Primary
Presence or Absence of Nausea and/or Vomiting
Presence or absence of nausea and/or vomiting, treated as a binary variable
Time frame: Up to 30 days after discharge
Population: Variable was not recorded.
Primary
Surgical Related Complications and Readmissions
Presence or absence of surgical complication (including readmission), treated as a binary variable
Time frame: Up to 30 days after discharge
Population: Data were not collected.
Secondary
Application of Sensors in a Hospital Setting
Adequate application of sensors, treated as a categorical variable
Time frame: Up to 3 months post discharge
Population: One patient (arm 2) removed consent prior to treatment initiation and outcome recording.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Usual Care) | Application of Sensors in a Hospital Setting | Adequate Sensor Application | 5 Participants |
| Arm I (Usual Care) | Application of Sensors in a Hospital Setting | Inadequate Sensor Application | 0 Participants |
| Arm II (Additional Mobility) | Application of Sensors in a Hospital Setting | Adequate Sensor Application | 11 Participants |
| Arm II (Additional Mobility) | Application of Sensors in a Hospital Setting | Inadequate Sensor Application | 0 Participants |
Secondary
Change in Exercise Habits Outside of the Hospital
Post study questionnaire .
Time frame: Up to 3 months post discharge
Population: This variable was not recorded.
Secondary
Mobility Quality of Life Questionnaire
The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire.
Time frame: Up to 3 months post discharge
Population: Data were not collected.
Secondary
Post-surgical Complications
The complication status (present/absent) and grades will be summarized by group and compared using Fisher's exact test or the chi-square test, as appropriate.
Time frame: Up to 30 days post discharge
Population: Data were not collected.
Secondary
Range of Joint Movement in Upper and Lower Joints of Body
Will be measured using the 3 dimensional (3D) motion tracking system (Xsens), to identify the minimum required level of mobility for better early postoperative course recovery.
Time frame: Up to 30 days after discharge
Population: Data were not collected.