Brief Summary
This pilot research trial studies continuous activity monitoring during fractionated radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study explores the use of fitness trackers to study the activity levels of patients before, during, and after radiation therapy and the use of weekly assessments to measure the patients' quality of life during radiation therapy. This may allow doctors to see if there is any relationship between activity levels, quality of life, treatment interruptions, hospitalizations, and clinical outcomes.
Brief Title
Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer
Detailed Description
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy.
SECONDARY OBJECTIVES:
I. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy.
II. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes.
OUTLINE:
Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.
I. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy.
SECONDARY OBJECTIVES:
I. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy.
II. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes.
OUTLINE:
Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Digestive System Carcinoma
Head and Neck Carcinoma
Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract
* Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract
* Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry
Inclusion Criteria
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract
* Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract
* Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02649569
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-4873
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study
Primary Outcomes
Outcome Description
This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables. Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables. Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o
Outcome Measure
Number of patients who complete most (>= 80%) of the protocol-specified assessments
Outcome Time Frame
Up to 4 weeks post-chemoradiation therapy
Outcome Description
This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables. Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables. Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o
Outcome Measure
Number of patients who successfully use the activity monitor (i.e. wearing the activity monitor throughout the treatment course)
Outcome Time Frame
Up to 4 weeks post-chemoradiation therapy
Secondary Ids
Secondary Id
NCI-2015-02292
Secondary Id
007067
Secondary Id
2015-4873
Secondary Id
P30CA013330
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nitin Ohri
Investigator Email
nitin.ohri@einsteinmed.org
Investigator Phone