Bone MetastasesNCT02715856
Telemonitoring After Surgery to Preserve Limb Function in Optimizing Mobility in Cancer Survivors With Skeletal Metastases
A study testing Monitoring Device, Physical Activity Measurement and Quality-of-Life Assessment in people with Bone Metastases and Cancer Survivor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Cancer Survivor, Metastatic Malignant Neoplasm in the Bone
- What is being tested?
- Monitoring Device, Physical Activity Measurement and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2016to 28 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Monitoring Device, Physical Activity Measurement, Quality-of-Life Assessment, Questionnaire Administration, Standard Follow-Up Care
- Keywords
- Bone metastases, Intramedullary nailing surgery, IM, Physical tasks, Surveys, Questionnaires, Smartphone, Tablet, Telemedicine, Telemonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring DeviceOther
Also called Monitor
Undergo surgical wound and physical activity monitoring
Physical Activity MeasurementOther
Also called Activity
Undergo physical activity measurement
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Standard Follow-Up CareProcedure or surgery
Undergo standard follow-up care
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Monitoring Device; Other: Physical Activity Measurement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Standard Follow-Up Care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (1)
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).
Measured: Up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study start13 Apr 2016
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Why it stopped: Due to software issues and depletion of funds the protocol was terminated early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert L Satcher, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715856
- Sponsor's protocol ID
- 2015-0966
- Other IDs
- NCI-2016-00544, 2015-0966, 2015-00051255-Y1, 2015
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2016
- Last updated
- 13 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Telemonitoring to Optimize the Mobility of Cancer Survivors With Skeletal Metastases After Surgery to Preserve Limb Function
- ClinicalTrials.gov ID
- NCT02715856
- Acronym / sponsor ID
- 2015-0966
- Keywords
- Bone metastases, Intramedullary nailing surgery, IM, Physical tasks, Surveys, Questionnaires, Smartphone, Tablet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to software issues and depletion of funds the protocol was terminated early
- Enrolment
- 70 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Posted 13 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (standard follow up, physical activity measurement) | Active comparator | Other: Physical Activity Measurement, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Standard Follow-Up Care, Other: Survey AdministrationPatients 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) | Experimental | Other: Monitoring Device, Other: Physical Activity Measurement, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Standard Follow-Up Care, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring DeviceAlso: MonitorUndergo surgical wound and physical activity monitoring | Other | Group II (mobile surveillance) |
| Physical Activity MeasurementAlso: ActivityUndergo physical activity measurement | Other | Group I (standard follow up, physical activity measurement), Group II (mobile surveillance) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (standard follow up, physical activity measurement), Group II (mobile surveillance) |
| Questionnaire AdministrationAncillary studies | Other | Group I (standard follow up, physical activity measurement), Group II (mobile surveillance) |
| Standard Follow-Up CareUndergo standard follow-up care | Procedure or surgery | Group I (standard follow up, physical activity measurement), Group II (mobile surveillance) |
| Survey AdministrationAncillary studies | Other | Group I (standard follow up, physical activity measurement), Group II (mobile surveillance) |
Primary outcome
Inter-Rater Agreement on the Physician Assessed Score
Time frame: 7 months
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.
1 secondary outcome
Completion of Follow-Up Assessments
Time frame: Up to 25 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Satcher principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring Device, Physical Activity Measurement and Quality-of-Life Assessment in people with Bone Metastases and Cancer Survivor, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-Rater Agreement on the Physician Assessed Score (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.