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

Not Applicable

Terminated

• Conditions: Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
• Interventions: Behavioral: biofeedback-mediated stress management (BFSM)

• Registration Number: NCT01685346
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-14
• Study Start: 2012-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biofeedback	biofeedback-mediated stress management (BFSM)	biofeedback-mediated stress management (BFSM)

Primary Outcome Measures

Name	Time	Method
Number of patients that are able to return for eight visits of BFSM	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 Outcome Measures

Name	Time	Method
Change in baseline of skin conductance	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 on the FACT-lung questionnaire	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 in baseline of digital peripheral temperature	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 the Patient Health Questionnaire (PHQ-*8)	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.
Number of patients able to complete the Quality of Life (QOL) questionnaires	16 weeks
Assess changes in distress thermometer from baseline	16 weeks	Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.
Change from baseline of the Hospital Anxiety and Depression Scale (HADS)	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 Electromyography (EMG)	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	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	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.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States