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Lung Heart Rate Variability (HRV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674450
Recruitment Status : Withdrawn (This study never enrolled any subjects. It was terminated due to staffing and technology changes.)
First Posted : September 17, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Behavioral: Heart Rate Variability Biofeedback Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study at a Single Institution of Heart Rate Variability Biofeedback on Lung Cancer Patients Receiving Radiation Thearpy
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional Behavioral: 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.




Primary Outcome Measures :
  1. EORTC QLQ-C30 Questionnaire [ Time Frame: 2 years ]

    Questionnaire developed to assess the quality of life of cancer patients. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

    Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.



Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 2 years ]
    Measure the quality and patterns of sleep in adults. It differentiates from "poor" and "good" sleep quality by measuring seven areas. The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score). Item 10 does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674450


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: William Levin Abramson Cancer Center
Publications:

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03674450    
Other Study ID Numbers: UPCC 05518
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases