A Pilot Study at a Single Institution of Heart Rate Variability Biofeedback on Lung Cancer Patients Receiving Radiation Thearpy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- EORTC QLQ-C30 Questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interventional
Intervention: Heart Rate Variability Biofeedback Training (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- Pittsburgh Sleep Quality Index (PSQI)(2 years)