Status:
UNKNOWN
Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Lead Sponsor:
Trinitas Comprehensive Cancer Center
Collaborating Sponsors:
Aptium Oncology Research Network
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
EARLY_PHASE1
Brief 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 t...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00945607
Start Date
July 1 2009
Last Update
July 25 2011
Active Locations (1)
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1
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207