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

NCT02649569 | Completed

• 4 other identifiers: 2015-4873NCI-2015-02292007067P30CA013330
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Digestive System Carcinoma; Head and Neck Carcinoma; Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Observational (continuous activity monitoring, questionnaires)

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.

Device: Monitoring Device; Other: Quality-of-Life Assessment

Interventions

Monitoring Device DEVICE

Wear activity monitor

Also known as: Monitor

Observational (continuous activity monitoring, questionnaires)

Quality-of-Life Assessment OTHER

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

Also known as: Quality of Life Assessment

Observational (continuous activity monitoring, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Planned treatment with fractionated (\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent

You may qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467-2490, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nitin Ohri

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (2)