Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

biofeedback-mediated stress management (BFSM)

Behavioral
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Last updated: July 10, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01685346
Principal SponsorCase Comprehensive Cancer Center
Last updated: July 10, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

Criteria

3 inclusion criteria required to participate
ECOG performance status 0-1
Patients with a new diagnosis of advanced (stage IV) non-small cell lung cancer (NSCLC)
Plan to receive care at the Taussig Cancer Center
3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
biofeedback-mediated stress management (BFSM)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, United StatesOpen Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center in Google Maps
SuspendedOne Study Center