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

Breast Cancer Clinical Trial

— 09-IM-01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00945607
• Other study ID #: 09-IM-01
• Status: Active, not recruiting
• Phase: Phase 0
• First received: July 22, 2009
• Last updated: July 21, 2011
• Start date: July 2009

Study information

• Verified date: July 2011
• Source: Trinitas Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• GRT (Guided Relaxation Training)
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.

Locations

Country	Name	City	State
United States	Trinitas Comprehensive Cancer Center	Elizabeth	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Trinitas Comprehensive Cancer Center	Aptium Oncology Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.		Endpoint	No
Primary	Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.		Endpoint	No
Secondary	Determining the effects of GRT on vital signs and self-reported levels of fatigue.		End Point	No
Secondary	Determining differences of perceived levels of stress among various racial and ethnic groups.		End Point	No