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

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Terminated

Conditions

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

Treatments

Behavioral: biofeedback-mediated stress management (BFSM)

Study type

Interventional

Funder types

Other

Identifiers

NCT01685346
CASE6512
12-874 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Biofeedback
Experimental group
Description:
biofeedback-mediated stress management (BFSM)
Treatment:
Behavioral: biofeedback-mediated stress management (BFSM)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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