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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
40
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
Time frame: Endpoint
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
Time frame: Endpoint
Determining the effects of GRT on vital signs and self-reported levels of fatigue.
Time frame: End Point
Determining differences of perceived levels of stress among various racial and ethnic groups.
Time frame: End Point
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