Lung Heart Rate Variability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-04-11

Brief Summary

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The purpose of this study is to examine the effects of heart-rate variability biofeedback training on lung cancer patients receiving definitive radiation therapy. The target population consists of non-small cell lung cancer (NSCLC) patients receiving 6 weeks of radiation therapy. The study will utilize the Physiolab GP8 heart rate variability and respiration system to collect data as well as several survey instruments to analyze quality of life measures. The goal is to show the HRV training can improve certain QOL measures like anxiety and sleep quality.

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

Group Type EXPERIMENTAL

Heart Rate Variability Biofeedback Training

Intervention Type BEHAVIORAL

The study will utilize the Physiolab GP8 heart rate variability and respiration system on a laptop computer used solely for the study with the proper security passwords to protect participant information. The equipment consists of two electrocardiogram sensors (one per wrist) attached by sports wrist bands, a respiration monitoring belt placed around the upper abdomen, two galvanic skin conductance sensors attached to the fingertips, and a thermistor sensor attached to one of the finger tips. Participants will perform a series of monitored breathing exercises.

Interventions

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Heart Rate Variability Biofeedback Training

The study will utilize the Physiolab GP8 heart rate variability and respiration system on a laptop computer used solely for the study with the proper security passwords to protect participant information. The equipment consists of two electrocardiogram sensors (one per wrist) attached by sports wrist bands, a respiration monitoring belt placed around the upper abdomen, two galvanic skin conductance sensors attached to the fingertips, and a thermistor sensor attached to one of the finger tips. Participants will perform a series of monitored breathing exercises.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participants must be older than 18 years of age
* Both women and men of all ethnic background are eligible to participate in the study.
* Must be diagnosed with non-small cell lung cancer and receiving 6 weeks of radiation therapy.
* Must be available and willing to participate in 4, approximately 1 hour HRV biofeedback treatment sessions.
* Signed informed consent

Exclusion Criteria

* Participant is younger than 18 or older than 70
* Diagnosed with early stage NSCLC
* Patients who are pregnant
* Patients with cardiac arrhythmias
* Patients with Pacemakers
* Patients taking beta-blockers
* Patients with any major mental illness, cognitive impairment
* Incapable of giving informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No