Wearable Exercise Trackers in Cancer Rehabilitation

NCT03042884 | Completed

• 1 other identifier: 2016-0671
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  14 days

Study Arms (2)

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.

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.

Behavioral: Questionnaires; Device: Wearable Exercise Tracker Watch

Interventions

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

Wearable Exercise Trackers - Inpatient Group; Wearable Exercise Trackers - Outpatient Group

Wearable Exercise Tracker Watch DEVICE

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.

Wearable Exercise Trackers - Inpatient Group; Wearable Exercise Trackers - Outpatient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \) Patients currently using a wearable activity tracker

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amy Ng, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 3, 2017
• Study Start: February 13, 2017
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (1)