Clinical trial NCT03674450: Lung Heart Rate Variability
Official title: A Pilot Study at a Single Institution of Heart Rate Variability Biofeedback on Lung Cancer Patients Receiving Radiation Thearpy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: EORTC QLQ-C30 Questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center
name: William Levin
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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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.
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.
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.
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.