Wearable Exercise Trackers in Cancer Rehabilitation

• ClinicalTrials.gov Identifier: NCT03042884
• Recruitment Status: Completed
• First Posted: February 3, 2017
• Last Update Posted: December 17, 2020
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Benign Neoplasms; In Situ Neoplasms; Malignant Neoplasms of Independent (Primary) Multiple Sites	Behavioral: Questionnaires; Device: Wearable Exercise Tracker Watch	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 111 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Wearable Exercise Trackers in Cancer Rehabilitation
• Actual Study Start Date: February 13, 2017
• Actual Primary Completion Date: December 14, 2020
• Actual Study Completion Date: December 14, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Wearable Exercise Trackers - Inpatient Group; 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.	Behavioral: Questionnaires; 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.; Other Name: Surveys; Device: Wearable Exercise Tracker Watch; 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.
Experimental: Wearable Exercise Trackers - Outpatient Group; 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.	Behavioral: Questionnaires; 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.; Other Name: Surveys; Device: Wearable Exercise Tracker Watch; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Men and women with literacy as demonstrated by reading and signing informed consent form
2. 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
3. Patients admitted to the acute inpatient rehabilitation unit and those seen in the Physical Medicine and Rehabilitation outpatient clinic
4. Capable of completing questionnaire in English

Exclusion Criteria:

1) Patients currently using a wearable activity tracker

Contacts and Locations

Locations

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Amy Ng, MD; M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT03042884
• Other Study ID Numbers: 2016-0671
• First Posted: February 3, 2017
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:

Benign Neoplasms; In Situ Neoplasms; Malignant Neoplasms of Independent (Primary) Multiple Sites; Wearable exercise trackers; Questionnaires; Surveys

Additional relevant MeSH terms:

Neoplasms