Measuring the Effect of Radiation Therapy on Patient Activity Levels

NCT ID: NCT02694380

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer Prostate Cancer Breast Cancer Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Head and Neck

Subjects with head and neck cancer receiving radiation therapy.

No interventions assigned to this group

Prostate

Subjects with prostate cancer receiving radiation therapy.

No interventions assigned to this group

Breast

Subjects with breast cancer receiving radiation therapy.

No interventions assigned to this group

Lung

Subjects with lung cancer receiving radiation therapy.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Colin E. Champ, MD

Assistant Clinical Professor University of Pittsburgh Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Colin Champ, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Department of Radiation Oncology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UPMC St. Margaret Department of Radiation Oncology

Pittsburgh, Pennsylvania, United States

Site Status

UPMC Shadyside Department of Radiation Oncology

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-160

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiation Pneumonitis After SBRT for NSCLC
NCT02428049 ACTIVE_NOT_RECRUITING