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Recruitment Status : Withdrawn (This study never enrolled any subjects.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
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Behavioral: Heart Rate Variability Biofeedback Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||William Levin||Abramson Cancer Center|