Measuring the Effect of Radiation Therapy on Patient Activity Levels

August 7, 2018 updated by: Colin E. Champ, MD, University of Pittsburgh
The goal of this study is to measure the effect of radiation therapy on the activity levels of patients. This will be achieved by tracking their activity levels during a treatment course of radiation therapy.

Study Overview

Status

Terminated

Conditions

Detailed Description

At the University of Pittsburgh (UPMC) St. Margaret and UPMC Shadyside, in the department of radiation oncology, breast, prostate, head and neck, and lung cancer patients will receive the standard treatment for their cancer and in no way will this study interfere with this treatment. Prior to initiation of radiation, consenting patients will be given Misfit activity tracking devices (accelerometers) to be worn on their wrist to track their activity levels throughout the course radiation therapy. Bracelets will be given to patients by the PI or co-investigators (MDs involved in patient's care) at date of consent and returned at completion of the study. The bracelets will track daily steps taken, calories burned, miles walked, and restful and restless sleep. Again, the purpose of the study is merely to measure the affect radiation therapy has on activity levels of patients.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15215
        • UPMC St. Margaret Department of Radiation Oncology
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Shadyside Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential subjects are initially referred to the Department of Radiation Oncology for their primary cancer diagnosis. Subjects that fit the diagnosis for this study may be offered participation.

Description

Inclusion Criteria:

  • Diagnosis of Breast, Prostate, Lung or Head and Neck Cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Ability to walk 100 feet without rest
  • Signed informed consent

Exclusion Criteria:

  • Any other noncutaneous cancer diagnosis under active treatment
  • Known metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Head and Neck
Subjects with head and neck cancer receiving radiation therapy.
Prostate
Subjects with prostate cancer receiving radiation therapy.
Breast
Subjects with breast cancer receiving radiation therapy.
Lung
Subjects with lung cancer receiving radiation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity level
Time Frame: up to 15 weeks
Misfit activity tracking devices (accelerometers) will be worn by patients to track their activity levels 1 day to 4 weeks before radiotherapy, during radiotherapy, and for 1 day to 4 weeks after radiotherapy.
up to 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Colin Champ, MD, UPMC Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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