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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Behavioral: biofeedback-mediated stress management (BFSM)

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that are able to return for eight visits of BFSM	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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients able to complete the Quality of Life (QOL) questionnaires		16 weeks
Assess changes in distress thermometer from baseline	Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.	16 weeks
Change from baseline on the FACT-lung questionnaire	Physical, social/family, emotional, and functional well-being on a 0-4 scale. O being not at all and 4 being very much.	16 weeks
Change from baseline of the Hospital Anxiety and Depression Scale (HADS)	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.	16 weeks
Change from baseline of the Patient Health Questionnaire (PHQ-*8)	8-Item depression health questionnaire based on a scale from 0-3. 0 meaning not at all and 3 meaning nearly every day.	16 weeks
Change in baseline of digital peripheral temperature	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.	16 weeks
Change in baseline of skin conductance	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.	16 weeks
Change from baseline of Electromyography (EMG)	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.	16 weeks
Change from baseline of respiratory rates	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.	16 weeks
Change from baseline of heart rates	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.	16 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Nathan Pennell, MD, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 11, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: advanced (stage IV) non-small cell lung cancer (NSCLC); biofeedback-mediated stress management (BFSM)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CASE6512; 12-874 (Other Identifier: Cleveland Clinic IRB)