Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries

NCT04000581 | Terminated Results DMC

• 2 other identifiers: I 80918NCI-2019-03139
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (5)

• Range of Joint Movement in Upper and Lower Joints of Body

  Up to 30 days after discharge

• Post-surgical Complications

  Up to 30 days post discharge

• Change in Exercise Habits Outside of the Hospital

  Up to 3 months post discharge

• Application of Sensors in a Hospital Setting

  Up to 3 months post discharge

• Mobility Quality of Life Questionnaire

  Up to 3 months post discharge

Study Arms (2)

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.

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.

Other: Physical Activity; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm I (usual care)

Physical Activity OTHER

Walk for minimum 30 minutes per day

Arm II (additional mobility)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care); Arm II (additional mobility)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Exercise

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Kris Attwood
• Organization: Roswell Park Comprehensive Cancer Center

Kris.Attwood@roswellpark.org

716-845-1300

Study Officials

• Khurshid A Guru

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 27, 2019
• Study Start: May 31, 2019
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: July 22, 2022
• Results First Posted: August 31, 2021

Record last verified: 2022-07

Locations

US (1)