Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer

Lung Carcinoma Clinical Trial

Official title:

Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649569
• Other study ID #: 2015-4873
• Secondary ID: NCI-2015-0229200
• Status: Completed
• Start date: June 2015
• Est. completion date: July 2017

Study information

• Verified date: May 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Digestive System Carcinoma
• Head and Neck Carcinoma
• Lung Carcinoma
• Lung Neoplasms

Intervention

Device:
• Monitoring Device
Wear activity monitor

Other:
• Quality-of-Life Assessment
Complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Montefiore Medical Center - Moses Campus	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who complete most (>= 80%) of the protocol-specified assessments	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	Up to 4 weeks post-chemoradiation therapy
Primary	Number of patients who successfully use the activity monitor (i.e. wearing the activity monitor throughout the treatment course)	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	Up to 4 weeks post-chemoradiation therapy