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


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients that are able to return for eight visits of BFSM

Outcome 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.

Outcome Time Frame:

16 weeks

Safety Issue:

No

Principal Investigator

Nathan Pennell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE6512

NCT ID:

NCT01685346

Start Date:

October 2012

Completion Date:

January 2015

Related Keywords:

  • Advanced (Stage IV) Non-small Cell Lung Cancer (NSCLC)
  • advanced (stage IV) non-small cell lung cancer (NSCLC)
  • biofeedback-mediated stress management (BFSM)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44195