Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2009

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The primary objectives of this study are to determine if the use of Guided Relaxation
Training (GRT) during cancer treatment in individuals with newly diagnosed breast cancer
increases their ability to cope as measured by the Coping Self-Efficacy Scale (CSES) and
reduces their perceived stress as measured by the Perceived Stress Scale (PSS).


This is a study of self-reported stress in individuals with newly diagnosed breast cancer.
Subjects will be randomized to either the standard of care (SOC) arm or the intervention
arm. The principle investigators will be blinded to the arm assignment. The intervention
utilized will be six weekly on-site GRT sessions. In addition, subjects will be provided
with a CD utilizing a standardized GRT script and music for home use twice daily during the
study period. During the intervention period, they will also be provided with a diary and
required to keep a record of date and time of CD utilization at home. The subjects will
also be required to record their stress level before and after each of the two home
sessions. The sessions must be at least 4 hours apart.

The SOC arm will consist of an education session with the nurse or nurse practitioner and
supportive care / symptom management as needed. This group will also be required to keep a
daily diary in which they record their stress levels twice daily, at intervals separated by
at least 4 hours.


We found this trial at
1
site
Elizabeth, New Jersey 07207
?
mi
from
Elizabeth, NJ
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