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Wearable Exercise Trackers in Cancer Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042884
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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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

Resource links provided by the National Library of Medicine


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.





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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042884


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Amy Ng, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03042884    
Other Study ID Numbers: 2016-0671
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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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:
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Neoplasms