Benign NeoplasmsNCT03042884
Wearable Exercise Trackers in Cancer Rehabilitation
A study testing Questionnaires and Wearable Exercise Tracker Watch in people with Benign Neoplasms and In Situ Neoplasms, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn how useful a wearable exercise tracker watch is to monitor your physical activity. This is an investigational study. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Neoplasms, In Situ Neoplasms, Malignant Neoplasms of Independent (Primary) Multiple Sites
- What is being tested?
- Questionnaires and Wearable Exercise Tracker Watch
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women with literacy as demonstrated by reading and signing informed consent form
- At least 18 years of age, since the rehabilitation unit and physical medicine and rehabilitation clinic is open to patients 18 years of age or older
- Patients admitted to the acute inpatient rehabilitation unit and those seen in the Physical Medicine and Rehabilitation outpatient clinic
- Capable of completing questionnaire in English
Who cannot join
- 1) Patients currently using a wearable activity tracker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn how useful a wearable exercise tracker watch is to monitor your physical activity.
This is an investigational study.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Read the detailed description
Inpatient:
If you agree to take part in this study, you will complete a questionnaire about any symptoms you may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete.
You will receive a wearable exercise tracker watch and an iPod touch. You should wear the exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be used to sync the data from the tracker watch to the study's activity database so the study team can view your activity. Instructions on how to use the tracker and how to sync the trackers to the iPod touch will be given to you and demonstrated by the research staff.
The research coordinator will be available to help you with any issues you may have while taking part in the study and will call you to answer any questions. You will be called on Day 3 (+/- 2 days) of the study and again at the end of the study. These calls should last about 5 minutes each time.
The wearable tracker will record your steps, sleep time, time spent doing physical activity, heart rate, and distance. You may choose to record the food you eat and mood. Your ability to keep wearing the watch will be measured.
You should wear the band loosely enough that it can move back and forth on your wrist. If it becomes too bothersome, you can take the watch off and put it back on after an hour.
You should regularly clean the band and your wrist, especially after your rehabilitation sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners which could get trapped beneath the band and irritate your skin. Always dry the band well before putting it back on.
If any of the devices are lost, stolen, or broken, you should tell the study staff right away. They will be replaced at no cost to you as long as you have followed the study doctor's instructions. After you complete the study, we ask that you return the devices to the study staff.
Within 24 hours before you are discharged, you will return the devices to the research staff. You will be asked to complete the same questionnaire about your symptoms and a questionnaire about your experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete. If you are unable to complete them in person, you will be given the option to complete them over the phone or electronically after you have been discharged. If you choose to complete them electronically, your e-mail address will be collected so the survey link can be sent to you. We ask that you complete the questionnaires within 1 week after you are discharged.
Information will be collected from your medical records about your daily living at the beginning and at the end of the study. Basic information, such as your name, date of birth, race, gender, economic background, and medical record number will also be collected.
Length of Study:
You participation on this study will be over after you complete the second set of questionnaires.
Outpatient:
If you agree to take part in this study, you will complete 2 questionnaires about any symptoms you may have had in the past 24 hours and your current level of physical function. These should take about 10 minutes total to complete.
You will receive a wearable exercise tracker watch and an iPod touch. You should wear the exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be used to sync the data from the tracker watch to the study's activity database so the study team can view your activity. Instructions on how to use the tracker and how to sync the trackers to the iPod touch will be given to you and demonstrated by the research staff.
The research coordinator will be available to help you with any issues you may have while taking part in the study and will call you to answer any questions. You will be called on Day 3 (+/- 2 days) of the study and again at the end of the study. These calls should last about 5 minutes each time.
The wearable tracker will record your steps, sleep time, time spent doing physical activity, heart rate, and distance. You may choose to record the food you eat and mood. Your ability to keep wearing the watch will be measured. No identifying information will be used on the devices.
You should wear the band loosely enough that it can move back and forth on your wrist. If it becomes too bothersome, you can take the watch off and put it back on after an hour.
You should regularly clean the band and your wrist, especially after your rehabilitation sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners which could get trapped beneath the band and irritate your skin. Always dry the band well before putting it back on.
If any of the devices are lost, stolen, or broken, you should tell the study staff right away. They will be replaced at no cost to you as long as you have followed the study doctor's instructions. After you complete the study, we ask that you return the devices to the study staff.
At the end of the 14-day period, you will be called by the study staff to remind you to complete the same 2 questionnaires about your symptoms and level of physical function. You will complete another questionnaire about your experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete.
If you choose to complete these forms electronically, they will be made available online with a link on the iPod. You may also choose to complete the questionnaires over the phone.
You will be asked to return the wearable tracker and iPod Touch to the research coordinator at your next routine clinic visit. If you are unable to return to the clinic, you will be asked to mail back the devices with the FedEx postage paid envelope provided to you when you started the study.
Basic information, such as your name, date of birth, race, gender, economic background, and medical record number will also be collected.
Length of Study:
You participation on this study will be over after you complete the second set of questionnaires.
- Conditions
- Benign Neoplasms, In Situ Neoplasms, Malignant Neoplasms of Independent (Primary) Multiple Sites
- Being tested
- Questionnaires, Wearable Exercise Tracker Watch
- Keywords
- Benign Neoplasms, In Situ Neoplasms, Malignant Neoplasms of Independent (Primary) Multiple Sites, Wearable exercise trackers, Questionnaires, Surveys
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Inpatient Group: Participants complete a questionnaire about any symptoms they may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete.
Within 24 hours of being discharged, same questionnaire about symptoms and a questionnaire about experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete.
Outpatient Group: Participants complete 2 questionnaires about any symptoms they may have had in the past 24 hours and their current level of physical function. These should take about 10 minutes total to complete.
At the end of the 14-day period, participant called by the study staff to remind them to complete the same 2 questionnaires about symptoms and level of physical function. Participants complete another questionnaire about their experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete.
Wearable Exercise Tracker WatchDevice
Inpatient Group: Participants receive a wearable exercise tracker watch upon admission to acute inpatient rehabilitation unit. Participant to wear the exercise tracker watch on their wrist for 24 hours a day. Device to be returned within 24 hours before being discharged.
Outpatient Group: Participants receive a wearable exercise tracker watch to wear on their wrist for 24 hours a day for 14 days. Device to be returned at next visit.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Exercise Trackers - Inpatient Group | Experimental | Questionnaires completed at baseline and within 24 hours of discharge.
Participant given a wearable exercise tracker to be worn 24 hours a day while in the acute inpatient rehabilitation unit. Receives: Behavioral: Questionnaires; Device: Wearable Exercise Tracker Watch |
| Wearable Exercise Trackers - Outpatient Group | Experimental | Questionnaires completed at baseline and again in 14 days.
Participant given a wearable exercise tracker to be worn 24 hours a day for 14 days. Receives: Behavioral: Questionnaires; Device: Wearable Exercise Tracker Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Edmonton Symptom Assessment Scale (ESAS-FS)
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Measured: 14 days
Usefulness of Exercise Tracker as an Outpatient Per Edmonton Symptom Assessment Scale (ESAS-FS)
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Measured: 14 days
Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Patient Reported Outcomes Measurement Information System (PROMIS)
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Measured: 14 days
Usefulness of Exercise Tracker as an Outpatient Per Patient Reported Outcomes Measurement Information System (PROMIS)
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start13 Feb 2017
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign NeoplasmsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Ng, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042884
- Sponsor's protocol ID
- 2016-0671
- Status last verified
- Dec 2020
- First submitted
- 30 Jan 2017
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Exercise Trackers in Cancer Rehabilitation
- ClinicalTrials.gov ID
- NCT03042884
- Acronym / sponsor ID
- 2016-0671
- Conditions
- Benign Neoplasms, In Situ Neoplasms, Malignant Neoplasms of Independent (Primary) Multiple Sites
- Keywords
- Benign Neoplasms, In Situ Neoplasms, Malignant Neoplasms of Independent (Primary) Multiple Sites, Wearable exercise trackers, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to learn how useful a wearable exercise tracker watch is to monitor your physical activity.
This is an investigational study.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
Detailed description
Inpatient:
If you agree to take part in this study, you will complete a questionnaire about any symptoms you may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete.
You will receive a wearable exercise tracker watch and an iPod touch. You should wear the exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be used to sync the data from the tracker watch to the study's activity database so the study team can view your activity. Instructions on how to use the tracker and how to sync the trackers to the iPod touch will be given to you and demonstrated by the research staff.
The research coordinator will be available to help you with any issues you may have while taking part in the study and will call you to answer any questions. You will be called on Day 3 (+/- 2 days) of the study and again at the end of the study. These calls should last about 5 minutes each time.
The wearable tracker will record your steps, sleep time, time spent doing physical activity, heart rate, and distance. You may choose to record the food you eat and mood. Your ability to keep wearing the watch will be measured.
You should wear the band loosely enough that it can move back and forth on your wrist. If it becomes too bothersome, you can take the watch off and put it back on after an hour.
You should regularly clean the band and your wrist, especially after your rehabilitation sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners which could get trapped beneath the band and irritate your skin. Always dry the band well before putting it back on.
If any of the devices are lost, stolen, or broken, you should tell the study staff right away. They will be replaced at no cost to you as long as you have followed the study doctor's instructions. After you complete the study, we ask that you return the devices to the study staff.
Within 24 hours before you are discharged, you will return the devices to the research staff. You will be asked to complete the same questionnaire about your symptoms and a questionnaire about your experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete. If you are unable to complete them in person, you will be given the option to complete them over the phone or electronically after you have been discharged. If you choose to complete them electronically, your e-mail address will be collected so the survey link can be sent to you. We ask that you complete the questionnaires within 1 week after you are discharged.
Information will be collected from your medical records about your daily living at the beginning and at the end of the study. Basic information, such as your name, date of birth, race, gender, economic background, and medical record number will also be collected.
Length of Study:
You participation on this study will be over after you complete the second set of questionnaires.
Outpatient:
If you agree to take part in this study, you will complete 2 questionnaires about any symptoms you may have had in the past 24 hours and your current level of physical function. These should take about 10 minutes total to complete.
You will receive a wearable exercise tracker watch and an iPod touch. You should wear the exercise tracker watch on your wrist for 24 hours a day (or as much as possible) while you are in the acute inpatient rehabilitation unit, even when you sleep. The iPod touch will be used to sync the data from the tracker watch to the study's activity database so the study team can view your activity. Instructions on how to use the tracker and how to sync the trackers to the iPod touch will be given to you and demonstrated by the research staff.
The research coordinator will be available to help you with any issues you may have while taking part in the study and will call you to answer any questions. You will be called on Day 3 (+/- 2 days) of the study and again at the end of the study. These calls should last about 5 minutes each time.
The wearable tracker will record your steps, sleep time, time spent doing physical activity, heart rate, and distance. You may choose to record the food you eat and mood. Your ability to keep wearing the watch will be measured. No identifying information will be used on the devices.
You should wear the band loosely enough that it can move back and forth on your wrist. If it becomes too bothersome, you can take the watch off and put it back on after an hour.
You should regularly clean the band and your wrist, especially after your rehabilitation sessions. Rinse the band with water or wipe it with a small amount of rubbing alcohol. Do not use hand soap, body soap, dish soap, hand sanitizers, cleaning wipes or household cleaners which could get trapped beneath the band and irritate your skin. Always dry the band well before putting it back on.
If any of the devices are lost, stolen, or broken, you should tell the study staff right away. They will be replaced at no cost to you as long as you have followed the study doctor's instructions. After you complete the study, we ask that you return the devices to the study staff.
At the end of the 14-day period, you will be called by the study staff to remind you to complete the same 2 questionnaires about your symptoms and level of physical function. You will complete another questionnaire about your experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete.
If you choose to complete these forms electronically, they will be made available online with a link on the iPod. You may also choose to complete the questionnaires over the phone.
You will be asked to return the wearable tracker and iPod Touch to the research coordinator at your next routine clinic visit. If you are unable to return to the clinic, you will be asked to mail back the devices with the FedEx postage paid envelope provided to you when you started the study.
Basic information, such as your name, date of birth, race, gender, economic background, and medical record number will also be collected.
Length of Study:
You participation on this study will be over after you complete the second set of questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Exercise Trackers - Inpatient Group | Experimental | Behavioral: Questionnaires, Device: Wearable Exercise Tracker WatchQuestionnaires completed at baseline and within 24 hours of discharge. Participant given a wearable exercise tracker to be worn 24 hours a day while in the acute inpatient rehabilitation unit. |
| Wearable Exercise Trackers - Outpatient Group | Experimental | Behavioral: Questionnaires, Device: Wearable Exercise Tracker WatchQuestionnaires completed at baseline and again in 14 days. Participant given a wearable exercise tracker to be worn 24 hours a day for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women with literacy as demonstrated by reading and signing informed consent form
- At least 18 years of age, since the rehabilitation unit and physical medicine and rehabilitation clinic is open to patients 18 years of age or older
- Patients admitted to the acute inpatient rehabilitation unit and those seen in the Physical Medicine and Rehabilitation outpatient clinic
- Capable of completing questionnaire in English
Key exclusion criteria (1 listed)
- 1) Patients currently using a wearable activity tracker
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 |
|---|---|---|
| QuestionnairesAlso: SurveysInpatient Group: Participants complete a questionnaire about any symptoms they may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete. Within 24 hours of being discharged, same questionnaire about symptoms and a questionnaire about experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete. Outpatient Group: Participants complete 2 questionnaires about any symptoms they may have had in the past 24 hours and their current level of physical function. These should take about 10 minutes total to complete. At the end of the 14-day period, participant called by the study staff to remind them to complete the same 2 questionnaires about symptoms and level of physical function. Participants complete another questionnaire about their experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete. | Behavioural | Wearable Exercise Trackers - Inpatient Group, Wearable Exercise Trackers - Outpatient Group |
| Wearable Exercise Tracker WatchInpatient Group: Participants receive a wearable exercise tracker watch upon admission to acute inpatient rehabilitation unit. Participant to wear the exercise tracker watch on their wrist for 24 hours a day. Device to be returned within 24 hours before being discharged. Outpatient Group: Participants receive a wearable exercise tracker watch to wear on their wrist for 24 hours a day for 14 days. Device to be returned at next visit. | Device | Wearable Exercise Trackers - Inpatient Group, Wearable Exercise Trackers - Outpatient Group |
Primary outcome
Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Edmonton Symptom Assessment Scale (ESAS-FS)
Time frame: 14 days
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Usefulness of Exercise Tracker as an Outpatient Per Edmonton Symptom Assessment Scale (ESAS-FS)
Time frame: 14 days
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 14 days
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Usefulness of Exercise Tracker as an Outpatient Per Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 14 days
Exercise tracker considered useful if at least 2/3 patients consider it as useful.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- University of Texas 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.
Amy Ng, MD 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 Questionnaires and Wearable Exercise Tracker Watch in people with Benign Neoplasms and In Situ Neoplasms, 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 4 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: finished, as of the sponsor's last update on 17 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usefulness of Exercise Tracker in Acute Inpatient Rehabilitation Unit Per Edmonton Symptom Assessment Scale (ESAS-FS) (time frame: 14 days). The study lists 4 primary outcomes in all. 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 17 Dec 2020.