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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Trinitas Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Aptium Oncology Research Network
Information provided by:
Trinitas Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00945607
First received: July 22, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Other: GRT (Guided Relaxation Training)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Guided Relaxation Training for the Reduction of Self-Reported Stress in Individuals With Newly Diagnosed Breast Cancer

Resource links provided by NLM:


Further study details as provided by Trinitas Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress. [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability. [ Time Frame: Endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determining the effects of GRT on vital signs and self-reported levels of fatigue. [ Time Frame: End Point ] [ Designated as safety issue: No ]
  • Determining differences of perceived levels of stress among various racial and ethnic groups. [ Time Frame: End Point ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945607

Locations
United States, New Jersey
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207
Sponsors and Collaborators
Trinitas Comprehensive Cancer Center
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
  More Information

No publications provided

Responsible Party: Carol Blecher, RN, MS, AOCN, APNC, Trinitas Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00945607     History of Changes
Other Study ID Numbers: 09-IM-01
Study First Received: July 22, 2009
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Trinitas Comprehensive Cancer Center:
Complementary Medicine
Alternative Medicine
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014