Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer (09-IM-01)
Recruitment status was Active, not recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
|Official Title:||Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer|
- Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress. [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
- Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability. [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
- Determining the effects of GRT on vital signs and self-reported levels of fatigue. [ Time Frame: End Point ] [ Designated as safety issue: No ]
- Determining differences of perceived levels of stress among various racial and ethnic groups. [ Time Frame: End Point ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Guided Relaxation Training
Eligible subjects who have been randomized to the intervention arm will be scheduled for GRT introduction and training with a research staff member. The GRT sessions will consist of six weekly on-site sessions in which the subject is provided instructions and then allowed to listen to the GRT CD. Subjects will be instructed to conduct independent GRT sessions at home, twice daily, at least four hours apart, for the duration of the study. Subjects will also be instructed that on the days of one-on-one sessions with a research staff member at TCCC, that they will only be required to perform the independent session once at home.
Subjects will be provided with a diary to record the date and time of each independent GRT session performed at home. Subjects will be instructed to bring their completed diary with them at each subsequent visit.
Other: GRT (Guided Relaxation Training)
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
No Intervention: Standard of Care(SOC)
Eligible subjects who are randomized to the SOC arm will not receive the GRT sessions. During the six week treatment phase, these subjects will only receive SOC provided to all subjects newly diagnosed with breast cancer at TCCC. This consists of an education session with the nurse or nurse practitioner. In addition, they will also be provided with supportive care and symptom management as needed. This arm will also be provided with a diary to record their stress level at least twice daily.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945607
|United States, New Jersey|
|Trinitas Comprehensive Cancer Center|
|Elizabeth, New Jersey, United States, 07207|
|Principal Investigator:||Carol S Blecher, RN, MS, AOCN, APNC||Trinitas Comprehensive Cancer Center|
|Principal Investigator:||Sharon Kurtz, RN, BSN, C.Ht.||Trinitas Comprehensive Cancer Center|