Malignant NeoplasmNCT04000581
Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries
A study testing Best Practice, Physical Activity and Questionnaire Administration in people with Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Best Practice, Physical Activity and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2019to 10 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Best Practice, Physical Activity, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Physical ActivityOther
Walk for minimum 30 minutes per day
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Best Practice; Other: Questionnaire Administration |
| 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. Receives: Other: Physical Activity; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 30 days after discharge
Early Discharge From the Hospital
Days from operation until hospital discharge, treated as continuous variable
Measured: Up to 30 days after discharge
Surgical Related Complications and Readmissions
Presence or absence of surgical complication (including readmission), treated as a binary variable
Measured: Up to 30 days after discharge
Secondary outcomes (5)
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.
Measured: Up to 30 days after discharge
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.
Measured: Up to 30 days post discharge
Change in Exercise Habits Outside of the Hospital
Post study questionnaire .
Measured: Up to 3 months post discharge
Application of Sensors in a Hospital Setting
Adequate application of sensors, treated as a categorical variable
Measured: 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.
Measured: Up to 3 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start31 May 2019
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Why it stopped: difficulty with equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khurshid A Guru, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000581
- Sponsor's protocol ID
- I 80918
- Other IDs
- NCI-2019-03139, I 80918
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2019
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Increased Mobility Assessed With 3D Motion Tracking Technology Lead to Early Post-Operative Recovery Among Patients Undergoing Oncologic Surgeries
- ClinicalTrials.gov ID
- NCT04000581
- Acronym / sponsor ID
- I 80918
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty with equipment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients 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 | Other: Physical Activity, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm I (usual care) |
| Physical ActivityWalk for minimum 30 minutes per day | Other | Arm II (additional mobility) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual care), Arm II (additional mobility) |
Primary outcome
Changes in Mobility
Time frame: 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
Time frame: 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
Time frame: Up to 30 days after discharge
Presence or absence of nausea and/or vomiting, treated as a binary variable
Presence or Absence of Chest Symptoms
Time frame: 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
Time frame: Up to 30 days after discharge
Days from operation until hospital discharge, treated as continuous variable
Surgical Related Complications and Readmissions
Time frame: Up to 30 days after discharge
Presence or absence of surgical complication (including readmission), treated as a binary variable
5 secondary outcomes
Range of Joint Movement in Upper and Lower Joints of Body
Time frame: Up to 30 days after discharge
Post-surgical Complications
Time frame: Up to 30 days post discharge
Change in Exercise Habits Outside of the Hospital
Time frame: Up to 3 months post discharge
Application of Sensors in a Hospital Setting
Time frame: Up to 3 months post discharge
Mobility Quality of Life Questionnaire
Time frame: Up to 3 months post discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khurshid A Guru principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Physical Activity and Questionnaire Administration in people with Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mobility (time frame: Baseline up to 30 days post discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.