Lung Heart Rate Variability

Not Applicable

Withdrawn

• Conditions: Non Small Cell Lung Cancer
• Interventions: Behavioral: Heart Rate Variability Biofeedback Training

• Registration Number: NCT03674450
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2019-01-02
• Primary Completion: 2019-04-11
• Study Completion: 2019-04-11
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Heart Rate Variability Biofeedback Training	-

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-C30 Questionnaire	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

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	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.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States