Trials / Terminated
TerminatedNCT01685346
Biofeedback Training in Patients With Advanced Lung Cancer - A Pilot Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Case Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2012-09-14
- Last updated
- 2015-07-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01685346. Inclusion in this directory is not an endorsement.