Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer (09-IM-01)

July 21, 2011 updated by: Trinitas Comprehensive Cancer Center
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Elizabeth, New Jersey, United States, 07207
        • Trinitas Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: GRT (Guided Relaxation Training)
Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.
NO_INTERVENTION: Standard of Care(SOC)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trinitas Comprehensive Cancer Center

Collaborators

Aptium Oncology Research Network

Investigators

  • Principal Investigator: Carol S Blecher, RN, MS, AOCN, APNC, Trinitas Comprehensive Cancer Center
  • Principal Investigator: Sharon Kurtz, RN, BSN, C.Ht., Trinitas Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2013

Study Registration Dates

First Submitted

July 22, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (ESTIMATE)

July 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-IM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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