Clinical trial NCT00945607: Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Official title: Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: Complementary Medicine
Alternative Medicine
Breast Cancer
Lead sponsor: Trinitas Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Aptium Oncology Research Network
First posted: 2009-07-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.
timeFrame: Endpoint
measure: Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.
timeFrame: Endpoint
Secondary outcomes:
measure: Determining the effects of GRT on vital signs and self-reported levels of fatigue.
timeFrame: End Point
measure: Determining differences of perceived levels of stress among various racial and ethnic groups.
timeFrame: End Point
Other outcomes:
Locations:
city: Elizabeth
country: United States
facility: Trinitas Comprehensive Cancer Center
state: New Jersey
Study officials:
affiliation: Trinitas Comprehensive Cancer Center
name: Carol S Blecher, RN, MS, AOCN, APNC
role: PRINCIPAL_INVESTIGATOR
affiliation: Trinitas Comprehensive Cancer Center
name: Sharon Kurtz, RN, BSN, C.Ht.
role: PRINCIPAL_INVESTIGATOR
References: