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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01685346
First received: September 10, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
Behavioral: biofeedback-mediated stress management (BFSM)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of patients that are able to return for eight visits of BFSM [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of patients able to complete the Quality of Life (QOL) questionnaires [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Assess changes in distress thermometer from baseline [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: October 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685346

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Nathan Pennell, MD Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01685346     History of Changes
Other Study ID Numbers: CASE6512, 12-874
Study First Received: September 10, 2012
Last Updated: July 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
advanced (stage IV) non-small cell lung cancer (NSCLC)
biofeedback-mediated stress management (BFSM)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014