Back to resultsGuided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer (09-IM-01)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
GRT (Guided Relaxation Training)
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Complementary Medicine, Alternative Medicine, Breast Cancer
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
Sites / Locations
- Trinitas Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Guided Relaxation Training
Standard of Care(SOC)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
Secondary Outcome Measures
Determining the effects of GRT on vital signs and self-reported levels of fatigue.
Determining differences of perceived levels of stress among various racial and ethnic groups.
Full Information
NCT ID
NCT00945607
First Posted
July 22, 2009
Last Updated
July 21, 2011
Sponsor
Trinitas Comprehensive Cancer Center
Collaborators
Aptium Oncology Research Network
1. Study Identification
Unique Protocol Identification Number
NCT00945607
Brief Title
Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Acronym
09-IM-01
Official Title
Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Trinitas Comprehensive Cancer Center
Collaborators
Aptium Oncology Research Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 to cope as measured by the Coping Self-Efficacy Scale (CSES) and reduces their perceived stress as measured by the Perceived Stress Scale (PSS).
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Complementary Medicine, Alternative Medicine, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided Relaxation Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care(SOC)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
GRT (Guided Relaxation Training)
Intervention Description
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
Primary Outcome Measure Information:
Title
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
Time Frame
Endpoint
Title
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
Time Frame
Endpoint
Secondary Outcome Measure Information:
Title
Determining the effects of GRT on vital signs and self-reported levels of fatigue.
Time Frame
End Point
Title
Determining differences of perceived levels of stress among various racial and ethnic groups.
Time Frame
End Point
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol S Blecher, RN, MS, AOCN, APNC
Organizational Affiliation
Trinitas Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon Kurtz, RN, BSN, C.Ht.
Organizational Affiliation
Trinitas Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trinitas Comprehensive Cancer Center
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
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