Biofeedback Training in Patients With Advanced Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Biofeedback

biofeedback-mediated stress management (BFSM)

Group Type EXPERIMENTAL

biofeedback-mediated stress management (BFSM)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No