Measuring the Effect of Radiation Therapy on Patient Activity Levels

NCT02694380 | Terminated DMC

• 1 other identifier: 15-160
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Head and Neck Cancer; Prostate Cancer; Breast Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Activity level

  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

Study Arms (4)

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.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

UPMC St. Margaret Department of Radiation Oncology

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Shadyside Department of Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Colin Champ, MD

  UPMC Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor University of Pittsburgh Radiation Oncology

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 29, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)