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Lung Heart Rate Variability (HRV)

Primary Purpose

Non Small Cell Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Rate Variability Biofeedback Training
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

Outcomes

Primary Outcome Measures

EORTC QLQ-C30 Questionnaire
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

Pittsburgh Sleep Quality Index (PSQI)
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.

Full Information

First Posted
September 10, 2018
Last Updated
April 3, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03674450
Brief Title
Lung Heart Rate Variability
Acronym
HRV
Official Title
A Pilot Study at a Single Institution of Heart Rate Variability Biofeedback on Lung Cancer Patients Receiving Radiation Thearpy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
This study never enrolled any subjects. It was terminated due to staffing and technology changes.
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Heart Rate Variability Biofeedback Training
Intervention Description
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 Measure Information:
Title
EORTC QLQ-C30 Questionnaire
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Levin
Organizational Affiliation
Abramson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11806675
Citation
Ancoli-Israel S, Moore PJ, Jones V. The relationship between fatigue and sleep in cancer patients: a review. Eur J Cancer Care (Engl). 2001 Dec;10(4):245-55. doi: 10.1046/j.1365-2354.2001.00263.x.
Results Reference
background
PubMed Identifier
14745853
Citation
Badger TA, Braden CJ, Mishel MH, Longman A. Depression burden, psychological adjustment, and quality of life in women with breast cancer: patterns over time. Res Nurs Health. 2004 Feb;27(1):19-28. doi: 10.1002/nur.20002.
Results Reference
background
PubMed Identifier
26629761
Citation
Guo Y, Koshy S, Hui D, Palmer JL, Shin K, Bozkurt M, Yusuf SW. Prognostic Value of Heart Rate Variability in Patients With Cancer. J Clin Neurophysiol. 2015 Dec;32(6):516-20. doi: 10.1097/WNP.0000000000000210.
Results Reference
background
PubMed Identifier
17219062
Citation
Hassett AL, Radvanski DC, Vaschillo EG, Vaschillo B, Sigal LH, Karavidas MK, Buyske S, Lehrer PM. A pilot study of the efficacy of heart rate variability (HRV) biofeedback in patients with fibromyalgia. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):1-10. doi: 10.1007/s10484-006-9028-0. Epub 2007 Jan 12.
Results Reference
background
PubMed Identifier
18183564
Citation
Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
Results Reference
background
PubMed Identifier
17333315
Citation
Karavidas MK, Lehrer PM, Vaschillo E, Vaschillo B, Marin H, Buyske S, Malinovsky I, Radvanski D, Hassett A. Preliminary results of an open label study of heart rate variability biofeedback for the treatment of major depression. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):19-30. doi: 10.1007/s10484-006-9029-z. Epub 2007 Mar 1.
Results Reference
background
PubMed Identifier
21243092
Citation
Liu L, Ancoli-Israel S. Sleep Disturbances in Cancer. Psychiatr Ann. 2008 Sep 1;38(9):627-634. doi: 10.3928/00485713-20080901-01. No abstract available.
Results Reference
background
PubMed Identifier
18286369
Citation
Reiner R. Integrating a portable biofeedback device into clinical practice for patients with anxiety disorders: results of a pilot study. Appl Psychophysiol Biofeedback. 2008 Mar;33(1):55-61. doi: 10.1007/s10484-007-9046-6. Epub 2008 Feb 20.
Results Reference
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Lung Heart Rate Variability

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