Breast Cancer Clinical Trial
Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Summary
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).
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Able to speak and understand English
At or between the ages of 18 and 75
Newly diagnosed with breast cancer (within 12 weeks of study entry)
Expected to receive chemotherapy and/or radiation
Willingness to complete CSES, PSS-14 and FACIT-F scales
Minimum score of 4 on the 0-10 Visual Analog Scale for stress
Willingness to participate for the 18 week duration of study and follow-up
Ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions
Access to a CD player
Exclusion Criteria:
Cognitive or mental status affecting ability to follow directions
Previous or current use of complementary therapies for their cancer diagnosis, except herbal supplements
Brain metastasis
Treatment for any other diagnosis of cancer within the previous 5 years
Any condition that, in the opinion of the investigator might interfere with the subject's participation in the study, pose an added risk for the subject or confound the assessment of the subject
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There is 1 Location for this study
Elizabeth New Jersey, 07207, United States
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