Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
Carol S Blecher, RN, MS, AOCN, APNC
Trinitas Comprehensive Cancer Center
United States: Institutional Review Board
|Trinitas Comprehensive Cancer Center||Elizabeth, New Jersey 07207|