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

Primary Purpose

Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
biofeedback-mediated stress management (BFSM)
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC) focused on measuring advanced (stage IV) non-small cell lung cancer (NSCLC), biofeedback-mediated stress management (BFSM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biofeedback

Arm Description

biofeedback-mediated stress management (BFSM)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients able to complete the Quality of Life (QOL) questionnaires
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 10, 2012
Last Updated
July 9, 2015
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01685346
Brief Title
Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study
Official Title
Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Research Cancelled
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
Keywords
advanced (stage IV) non-small cell lung cancer (NSCLC), biofeedback-mediated stress management (BFSM)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biofeedback
Arm Type
Experimental
Arm Description
biofeedback-mediated stress management (BFSM)
Intervention Type
Behavioral
Intervention Name(s)
biofeedback-mediated stress management (BFSM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients that are able to return for eight visits of BFSM
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Number of patients able to complete the Quality of Life (QOL) questionnaires
Time Frame
16 weeks
Title
Assess changes in distress thermometer from baseline
Description
Distress Thermometer questionnaire using a scale of 0-10. O meaning no distress and 10 meaning extreme distress.
Time Frame
16 weeks
Title
Change from baseline on the FACT-lung questionnaire
Description
Physical, social/family, emotional, and functional well-being on a 0-4 scale. O being not at all and 4 being very much.
Time Frame
16 weeks
Title
Change from baseline of the Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
16 weeks
Title
Change from baseline of the Patient Health Questionnaire (PHQ-*8)
Description
8-Item depression health questionnaire based on a scale from 0-3. 0 meaning not at all and 3 meaning nearly every day.
Time Frame
16 weeks
Title
Change in baseline of digital peripheral temperature
Description
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.
Time Frame
16 weeks
Title
Change in baseline of skin conductance
Description
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.
Time Frame
16 weeks
Title
Change from baseline of Electromyography (EMG)
Description
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.
Time Frame
16 weeks
Title
Change from baseline of respiratory rates
Description
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.
Time Frame
16 weeks
Title
Change from baseline of heart rates
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Pennell, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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