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

NCT ID: NCT02715856

Last Updated: 2022-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-13

Study Completion Date

2021-09-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bone Metastases Cancer Survivor Metastatic Malignant Neoplasm in the Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group I (standard follow up, physical activity measurement)

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 Type ACTIVE_COMPARATOR

Physical Activity Measurement

Intervention Type OTHER

Undergo physical activity measurement

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Standard Follow-Up Care

Intervention Type PROCEDURE

Undergo standard follow-up care

Survey Administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Monitoring Device

Intervention Type OTHER

Undergo surgical wound and physical activity monitoring

Physical Activity Measurement

Intervention Type OTHER

Undergo physical activity measurement

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Standard Follow-Up Care

Intervention Type PROCEDURE

Undergo standard follow-up care

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Monitoring Device

Undergo surgical wound and physical activity monitoring

Intervention Type OTHER

Physical Activity Measurement

Undergo physical activity measurement

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Standard Follow-Up Care

Undergo standard follow-up care

Intervention Type PROCEDURE

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Monitor Activity Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion:

N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert L Satcher

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2016-00544

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0966

Identifier Type: OTHER

Identifier Source: secondary_id

2015-00051255-Y1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2015-0966

Identifier Type: -

Identifier Source: org_study_id

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