Clinical trial NCT02649569: Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer
Official title: Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive System Carcinoma
Head and Neck Carcinoma
Lung Carcinoma
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-01-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent

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.

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.

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

Primary outcomes:
measure: Number of patients who complete most (>= 80%) of the protocol-specified assessments
timeFrame: Up to 4 weeks post-chemoradiation therapy
measure: Number of patients who successfully use the activity monitor (i.e. wearing the activity monitor throughout the treatment course)
timeFrame: Up to 4 weeks post-chemoradiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Nitin Ohri
role: PRINCIPAL_INVESTIGATOR
References: