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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00544 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-0966 | Other Identifier | M D Anderson Cancer Center | |
| 2015-00051255-Y1 | Other Grant/Funding Number | Cancer Survivorship Research Seed Money Grant |
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Due to software issues and depletion of funds the protocol was terminated early
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring Device | Other | Undergo surgical wound and physical activity monitoring |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Follow-Up Assessments | 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). | Up to 25 weeks |
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Inclusion Criteria:
Exclusion:
N/A
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Satcher | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 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. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2018 |
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| Physical Activity Measurement | Other | Undergo physical activity measurement |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Standard Follow-Up Care | Procedure | Undergo standard follow-up care |
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| Survey Administration | Other | Ancillary studies |
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| FG001 | Phase 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. 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 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. 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 |
| BG001 | Phase 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. 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | 7 months |
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| Secondary | Completion of Follow-Up Assessments | 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). | 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. | Posted | Up to 25 weeks |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 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. 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 | 6 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Phase 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. 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 | 5 | 52 | 0 | 52 | 0 | 52 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Satcher, Associate Professor, Orthopaedic Oncology | UT MD Anderson Cancer Center | (713) 794-5242 | rlsatcher@mdanderson.org |
| Sep 13, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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