Clinical trial NCT01685346: 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
Overall status: TERMINATED
Phase: NA
Conditions: Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
Keywords: advanced (stage IV) non-small cell lung cancer (NSCLC)
biofeedback-mediated stress management (BFSM)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of patients that are able to return for eight visits of BFSM
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of patients able to complete the Quality of Life (QOL) questionnaires
timeFrame: 16 weeks
measure: Assess changes in distress thermometer from baseline
timeFrame: 16 weeks
measure: Change from baseline on the FACT-lung questionnaire
timeFrame: 16 weeks
measure: Change from baseline of the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 16 weeks
measure: Change from baseline of the Patient Health Questionnaire (PHQ-*8)
timeFrame: 16 weeks
measure: Change in baseline of digital peripheral temperature
timeFrame: 16 weeks
measure: Change in baseline of skin conductance
timeFrame: 16 weeks
measure: Change from baseline of Electromyography (EMG)
timeFrame: 16 weeks
measure: Change from baseline of respiratory rates
timeFrame: 16 weeks
measure: Change from baseline of heart rates
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
name: Nathan Pennell, MD
role: PRINCIPAL_INVESTIGATOR
References: