Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03139 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 80918 | Other Identifier | Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
difficulty with equipment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (usual care) | Active Comparator | 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 (additional mobility) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 30 days post discharge |
| Early Return of Bowel Motion | Days from operation to passing flatus and/or stool, treated as continuous measure | Up to 30 days after discharge |
| Presence or Absence of Nausea and/or Vomiting | Presence or absence of nausea and/or vomiting, treated as a binary variable | Up to 30 days after discharge |
| 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 | Up to 30 days after discharge |
| Early Discharge From the Hospital | Days from operation until hospital discharge, treated as continuous variable | Up to 30 days after discharge |
| Surgical Related Complications and Readmissions | Presence or absence of surgical complication (including readmission), treated as a binary variable | Up to 30 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days after discharge |
| Post-surgical Complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Khurshid A Guru | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | In the intervention arm, 2 patients have missing age. One patient removed their consent prior to any intervention. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One patient (arm 2) removed consent prior to treatment initiation and outcome recording. | Posted | Mean | Standard Deviation | m/s | Baseline up to 30 days post discharge |
|
Subjects will be followed 30 days post discharge to note any complications or readmission.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Attwood | Roswell Park Comprehensive Cancer Center | 716-845-1300 | Kris.Attwood@roswellpark.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2020 | Jun 23, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2020 | Jan 5, 2021 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Physical Activity | Other | Walk for minimum 30 minutes per day |
|
| Questionnaire Administration | Other | Ancillary studies |
|
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. |
| Up to 30 days post discharge |
| Change in Exercise Habits Outside of the Hospital | Post study questionnaire . | Up to 3 months post discharge |
| Application of Sensors in a Hospital Setting | Adequate application of sensors, treated as a categorical variable | Up to 3 months post discharge |
| Mobility Quality of Life Questionnaire | The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire. | Up to 3 months post discharge |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Two patients do not have age recorded. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Sex was not recorded. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Godin Score | Godin Leisure Time Exercise Questionnaire Score
| The baseline Godin Score was not obtained for 4 subjects. | Mean | Standard Deviation | units on a scale |
|
| 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 |
|
|
|
| Primary | Early Return of Bowel Motion | Days from operation to passing flatus and/or stool, treated as continuous measure | One patient (arm 2) removed consent prior to treatment initiation and outcome recording. | Posted | Mean | Standard Deviation | days | Up to 30 days after discharge |
|
|
|
| Primary | Presence or Absence of Nausea and/or Vomiting | Presence or absence of nausea and/or vomiting, treated as a binary variable | Variable was not recorded. | Posted | Up to 30 days after discharge |
|
|
| 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 | Variable was not recorded. | Posted | Up to 30 days after discharge |
|
|
| Primary | Early Discharge From the Hospital | Days from operation until hospital discharge, treated as continuous variable | One patient (arm II) removed consent prior to treatment initiation and outcome recording. | Posted | Mean | Standard Deviation | days | Up to 30 days after discharge |
|
|
|
| Primary | Surgical Related Complications and Readmissions | Presence or absence of surgical complication (including readmission), treated as a binary variable | Data were not collected. | Posted | Up to 30 days after discharge |
|
|
| 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. | Data were not collected. | Posted | Up to 30 days after discharge |
|
|
| 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. | Data were not collected. | Posted | Up to 30 days post discharge |
|
|
| Secondary | Change in Exercise Habits Outside of the Hospital | Post study questionnaire . | This variable was not recorded. | Posted | Up to 3 months post discharge |
|
|
| Secondary | Application of Sensors in a Hospital Setting | Adequate application of sensors, treated as a categorical variable | One patient (arm 2) removed consent prior to treatment initiation and outcome recording. | Posted | Count of Participants | Participants | Up to 3 months post discharge |
|
|
|
| Secondary | Mobility Quality of Life Questionnaire | The correlation between complication status and changes in mobility may be evaluated using a post study questionnaire. | Data were not collected. | Posted | Up to 3 months post discharge |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |