Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

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.

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.

Undergo surgical wound and physical activity monitoring

Monitoring Device

Physical Activity Measurement

Quality-of-Life Assessment

Questionnaire Administration

Standard Follow-Up Care

Survey Administration

Robert L Satcher

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.

PRIMARY OBJECTIVES:

I. To develop and evaluate the feasibility of a method that enhances surveillance in cancer survivors by using mobile devices in addition to face-to-face visits following surgery for bone metastases.

SECONDARY OBJECTIVES:

I. To evaluate how well the face-to-face follow-up format can be adapted to using mobile devices for remote surveillance.

II. Limited efficacy testing of the remote surveillance program. III. To obtain information on acceptability of the mobile surveillance format by patients and clinicians.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (CONTROL): 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.

GROUP II (MOBILE SURVEILLANCE): 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.

After completion of study, patients are followed up at 24-25 weeks.

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

Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function

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.

Participant considered having completed the follow-up assessments if the three outcomes are documented for the 2-, 6-, 12, and 24-week evaluations. Follow-up assessment information taken from Musculoskeletal Tumor Society Scores (MSTS), Timed "Up and Go" test (TUG), and Patient Reported Outcomes Measurement Information System (PROMIS).

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

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.

Physical Activity Measurement: Undergo physical activity measurement

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Standard Follow-Up Care: Undergo standard follow-up care

Survey Administration: Ancillary studies

Phase I (Standard Follow up, Physical Activity Measurement)

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.

Monitoring Device: Undergo surgical wound and physical activity monitoring

Physical Activity Measurement: Undergo physical activity measurement

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Standard Follow-Up Care: Undergo standard follow-up care

Survey Administration: Ancillary studies

Phase II (Mobile Surveillance)

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

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.

Dr. Robert Satcher, Associate Professor, Orthopaedic Oncology

Inter-Rater Agreement on the Physician Assessed Score

Completion of Follow-Up Assessments

Phase I (Control)

Overall Study

Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based PRO questionnaire, and weigh themselves daily for 60 days.

Accelerometer

Laboratory Biomarker Analysis

Perform physical activities recorded by Microsoft Kinect 2

Telephone-Based Intervention

Jorge Nieva

This clinical trial studies movement tracking devices in optimizing and monitoring physical activity in patients with solid tumors undergoing chemotherapy in a health care facility during the day without spending the night. Movement tracking devices, such as Microsoft Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.

PRIMARY OBJECTIVES:

I. To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.

SECONDARY OBJECTIVES:

I. To evaluate the association between activity and patient reported fatigue. II. To evaluate the association between movement and incidents of health care interventions (hospitalizations, physical visits, intravenous hydration, etc.)

TERTIARY OBJECTIVES:

I. To compare physician and patient assessed Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status scores with the data obtained from movement trackers.

OUTLINE:

Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based patient reported outcome (PRO) questionnaire, and weigh themselves daily for 60 days.

After completion of study, patients are followed up at 90 days.

Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

Accelerometry to Optimize and Monitor Human Performance in Cancer Chemotherapy Outpatients

The association between the "get up and go" time and moving onto the examination table will be explored.

The association between the presence of circulating tumor cells and patient activity will be explored.

The association between patient movement and the sum of inpatient and outpatient hospital encounters up to 90 days after study discontinuation will be explored.

Patients who are unable to comply and have data transmitted, including technical failures, personal decision, hospitalization, or any other reason are counted as "data capture failures". Data from patients who die while on study will not be replaced but will be included prior to their date of death, days between death and day 60 will not be included in the denominator when calculating "data capture success" rates.

The relationship between the change in weight over time and patient activity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases	NCT02715856	Bone Metastases Cancer Survivor Metastatic Mali...	Monitoring Devi... Physical Activi... Quality-of-Life... Questionnaire A... Standard Follow... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy	NCT03098277	Solid Neoplasm	Accelerometer Laboratory Biom... Physical Activi... Telephone-Based...	18 Years -	University of Southern California

Spots Global Cancer Trial Database for physical activity measurement