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

Early Phase 1

• Conditions: Breast Cancer
• Interventions: Other: GRT (Guided Relaxation Training)

• Registration Number: NCT00945607
• Lead Sponsor: Trinitas Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-25
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Relaxation Training	GRT (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.

Primary Outcome Measures

Name	Time	Method
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.	Endpoint
Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.	Endpoint

Secondary Outcome Measures

Name	Time	Method
Determining differences of perceived levels of stress among various racial and ethnic groups.	End Point
Determining the effects of GRT on vital signs and self-reported levels of fatigue.	End Point

Trial Locations

Locations (1)

Trinitas Comprehensive Cancer Center; 🇺🇸 Elizabeth, New Jersey, United States