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Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer


Phase 0
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.

Outcome Time Frame:

Endpoint

Safety Issue:

No

Principal Investigator

Carol S Blecher, RN, MS, AOCN, APNC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Trinitas Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-IM-01

NCT ID:

NCT00945607

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Complementary Medicine
  • Alternative Medicine
  • Breast Cancer
  • Breast Neoplasms

Name

Location
Trinitas Comprehensive Cancer Center Elizabeth, New Jersey  07207