NCT00945607

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).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

4 years

First QC Date

July 22, 2009

Last Update Submit

July 21, 2011

Conditions

Breast Cancer

Keywords

Complementary MedicineAlternative MedicineBreast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Determining the effects of GRT on vital signs and self-reported levels of fatigue.

    End Point

  • Determining differences of perceived levels of stress among various racial and ethnic groups.

    End Point

Study Arms (2)

Guided Relaxation Training

EXPERIMENTAL

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)

Standard of Care(SOC)

NO INTERVENTION

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.

Interventions

GRT (Guided Relaxation Training)OTHER

Weekly on-site GRT sessions at the center in combination with twice daily independent GRT sessions at home.

Guided Relaxation Training

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trinitas Comprehensive Cancer Center

Elizabeth, New Jersey, 07207, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carol S Blecher, RN, MS, AOCN, APNC

    Trinitas Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Sharon Kurtz, RN, BSN, C.Ht.

    Trinitas Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2013

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

US(1)