Biofeedback Training in Patients With Advanced Lung Cancer – A Pilot Study

Overview

This is a pilot study to test the hypothesis that biofeedback-mediated stress management (BFSM) training can be used to reduce distress and enhance quality of life in patients with non-small cell lung cancer (NSCLC). Most patients with advanced NSCLC have significant physical symptoms, but even those who do not have physical symptoms have high levels of anxiety and depression.

Full Title of Study: “Biofeedback Training in Patients With Advanced Lung Cancer – A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2014

Detailed Description

Biofeedback-mediated stress management (BFSM) involves helping patients to visualize the reactions which their own bodies have to stressful situations (increased heart rate, increased skin conductance, increased muscle tension, decreased digital peripheral temperature, decreased heart rate variability) and then teaching them to control these reactions, using standard stress management and relaxation techniques, coupled with computerized physiological feedback. The feedback helps patients to understand that deep relaxation is helping their bodies as well as their minds. Several small studies of BFSM training in cancer populations have been successful at helping with side effects of chemotherapy and radiation, but the effects of BFSM on distress and quality of life (QOL), particularly in NSCLC patients, have not been studied.

Interventions

  • Behavioral: biofeedback-mediated stress management (BFSM)
    • Therapist and study assistant meet with patient, attach sensors, record physiologic variables and train the patient in relaxation techniques including deep breathing, guided imagery, progressive muscle relaxation, autogenics. Patient is given a handheld thermometer to take home and practice self-regulation between visits, along with a recording sheet to indicate how often practice occurs.

Arms, Groups and Cohorts

  • Experimental: Biofeedback
    • biofeedback-mediated stress management (BFSM)

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients that are able to return for eight visits of BFSM
    • Time Frame: 16 weeks
    • Keep track of how many visits the patients attend, how many they cancel, and what other difficulties are encounter in getting them to return for eight visits.

Secondary Measures

  • Number of patients able to complete the Quality of Life (QOL) questionnaires
    • Time Frame: 16 weeks
  • Assess changes in distress thermometer from baseline
    • Time Frame: 16 weeks
    • Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.
  • Change from baseline on the FACT-lung questionnaire
    • Time Frame: 16 weeks
    • Physical, social/family, emotional, and functional well-being on a 0-4 scale. O being not at all and 4 being very much.
  • Change from baseline of the Hospital Anxiety and Depression Scale (HADS)
    • Time Frame: 16 weeks
    • Questionnaire to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data.
  • Change from baseline of the Patient Health Questionnaire (PHQ-*8)
    • Time Frame: 16 weeks
    • 8‐Item depression health questionnaire based on a scale from 0-3. 0 meaning not at all and 3 meaning nearly every day.
  • Change in baseline of digital peripheral temperature
    • Time Frame: 16 weeks
    • Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
  • Change in baseline of skin conductance
    • Time Frame: 16 weeks
    • Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
  • Change from baseline of Electromyography (EMG)
    • Time Frame: 16 weeks
    • Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
  • Change from baseline of respiratory rates
    • Time Frame: 16 weeks
    • Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.
  • Change from baseline of heart rates
    • Time Frame: 16 weeks
    • Compare the baseline measurement during the first five minutes of the session, the peak response to mental stress during the next ten minutes of the session, and the response during the self-relaxation period following the mental stress. An improvement would indicate success with biofeedback.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with a new diagnosis of advanced (stage IV) non-small cell lung cancer (NSCLC)
  • ECOG performance status 0-1.
  • Plan to receive care at the Taussig Cancer Center.

Exclusion Criteria

  • Non-local patients, who will not have the ability to return for 8 study visits.
  • Patients who are unable to speak and understand English readily,
  • Patients with significant cognitive impairment.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nathan Pennell, MD, Principal Investigator, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

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