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

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

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01685346
• Other study ID #: CASE6512
• Secondary ID: 12-874
• Status: Terminated
• Phase: N/A
• First received: September 10, 2012
• Last updated: July 9, 2015
• Start date: October 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of patients able to complete the Quality of Life (QOL) questionnaires		16 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No