Measuring the Effect of Radiation Therapy on Patient Activity Levels

Breast Cancer Clinical Trial

Official title:

Measuring the Effect of Radiation Therapy on Patient Activity Levels

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02694380
• Other study ID #: 15-160
• Status: Terminated
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Prostate Cancer

Locations

Country	Name	City	State
United States	UPMC Shadyside Department of Radiation Oncology	Pittsburgh	Pennsylvania
United States	UPMC St. Margaret Department of Radiation Oncology	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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