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TerminatedNCT02694380Updated Aug 9, 2018

Measuring the Effect of Radiation Therapy on Patient Activity Levels

An observational study in Head and Neck Cancer, Prostate Cancer and Breast Cancer, sponsored by University of Pittsburgh. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-09.

Sponsored by University of Pittsburgh · Observational

Why this study was terminated
Low accrual
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
32
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Head and Neck Cancer
  • Prostate Cancer
  • Breast Cancer
  • Lung Cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 32 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: up to 15 weeks

07

Study locations

2 sites
  • UPMC St. Margaret Department of Radiation Oncology
    Pittsburgh, Pennsylvania 15215, United States
  • UPMC Shadyside Department of Radiation Oncology
    Pittsburgh, Pennsylvania 15232, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02694380
Lead sponsor
University of Pittsburgh
Responsible party
Colin E. Champ, MD (Assistant Clinical Professor University of Pittsburgh Radiation Oncology, University of Pittsburgh) — Principal investigator
First posted
Feb 29, 2016
Start date
Jul 2015
Primary completion
Jul 2018
Completion
Jul 2018
Last update
Aug 9, 2018

Study contacts

Colin Champ, MD
principal investigator · UPMC Department of Radiation Oncology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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