Head and Neck CancerNCT02694380
Measuring the Effect of Radiation Therapy on Patient Activity Levels
An observational study of Head and Neck Cancer and Prostate Cancer, run by University of Pittsburgh at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Prostate Cancer, Breast Cancer
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Any other noncutaneous cancer diagnosis under active treatment
- Known metastatic disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC St. Margaret Department of Radiation Oncology
Pittsburgh, Pennsylvania, 15215
UPMC Shadyside Department of Radiation Oncology
Pittsburgh, Pennsylvania, 15232
About this study
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.
- Conditions
- Head and Neck Cancer, Prostate Cancer, Breast Cancer, Lung Cancer
- Medical subject headings
- Head and Neck Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin E. Champ, MD, University of Pittsburgh
- Investigators
- Colin Champ, MD, Principal investigator, UPMC Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694380
- Sponsor's protocol ID
- 15-160
- Status last verified
- Aug 2018
- First submitted
- 27 Jan 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effect of Radiation Therapy on Patient Activity Levels
- ClinicalTrials.gov ID
- NCT02694380
- Acronym / sponsor ID
- 15-160
- Conditions
- Head and Neck Cancer, Prostate Cancer, Breast Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Any other noncutaneous cancer diagnosis under active treatment
- Known metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Champ, MD principal investigator
UPMC Department of Radiation Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Prostate Cancer, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity level (time frame: up to 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.