Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases

NCT02715856 | Terminated Results FDA Drug

• 3 other identifiers: 2015-0966NCI-2016-005442015-00051255-Y1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot trial studies telemonitoring after surgery to preserve limb function in optimizing mobility in cancer survivors with cancer spread to the bone. The use of mobile devices for telemonitoring may improve the delivery of cost-effective, high-quality, standardized surveillance of cancer survivors.

Conditions

Bone Metastases; Cancer Survivor; Metastatic Malignant Neoplasm in the Bone

Keywords

Bone metastases; Intramedullary nailing surgery; IM; Physical tasks; Surveys; Questionnaires; Smartphone; Tablet; Telemedicine; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Inter-Rater Agreement on the Physician Assessed Score

  Inter-rater agreement on the physician assessed score defined as less than 10% difference between the Musculoskeletal Tumor Society (MSTS) scores evaluated using video vs. face-to-face follow ups.

  7 months

Secondary Outcomes (1)

• Completion of Follow-Up Assessments

  Up to 25 weeks

Study Arms (2)

Group I (standard follow up, physical activity measurement)

ACTIVE COMPARATOR

Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes.

Other: Physical Activity Measurement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Standard Follow-Up Care; Other: Survey Administration

Group II (mobile surveillance)

EXPERIMENTAL

Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery.

Other: Monitoring Device; Other: Physical Activity Measurement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Standard Follow-Up Care; Other: Survey Administration

Interventions

Monitoring Device OTHER

Undergo surgical wound and physical activity monitoring

Also known as: Monitor

Group II (mobile surveillance)

Physical Activity Measurement OTHER

Undergo physical activity measurement

Also known as: Activity

Group I (standard follow up, physical activity measurement); Group II (mobile surveillance)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (standard follow up, physical activity measurement); Group II (mobile surveillance)

Questionnaire Administration OTHER

Ancillary studies

Group I (standard follow up, physical activity measurement); Group II (mobile surveillance)

Standard Follow-Up Care PROCEDURE

Undergo standard follow-up care

Group I (standard follow up, physical activity measurement); Group II (mobile surveillance)

Survey Administration OTHER

Ancillary studies

Group I (standard follow up, physical activity measurement); Group II (mobile surveillance)

Eligibility Criteria

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

You may qualify if:

• Have been scheduled for an intramedullary nailing (IM) surgery with the department of Orthopaedic Oncology at University of Texas (UT) MD Anderson Cancer Center
• Are able to read and write English 3) Are 18 years or older
• Are willing and able to use a smartphone or tablet comfortably
• Have access to mobile hot spot, wireless internet, and/or cellular service
• Must have a caregiver or assistance at home who can assist with collecting physical therapy (PT) measures

You may not qualify if:

• N/A

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Continuous Glucose Monitoring; Exercise

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Due to software issues and depletion of funds the protocol was terminated early and the participants did not complete assessments per protocol at given point, no data collected.

Results Point of Contact

• Title: Dr. Robert Satcher, Associate Professor, Orthopaedic Oncology
• Organization: UT MD Anderson Cancer Center

rlsatcher@mdanderson.org

(713) 794-5242

Study Officials

• Robert L Satcher

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: April 13, 2016
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: October 13, 2022
• Results First Posted: October 13, 2022

Record last verified: 2022-10

Locations

US (1)