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Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer

This study has been completed.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031772
  Purpose

RATIONALE: Telephone counseling by breast cancer survivors may enhance the well-being and quality of life of women who have recurrent breast cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer.


Condition Intervention
Breast Cancer
Psychosocial Effects/Treatment
Quality of Life
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other
Official Title:   Enhancing Well-Being During Breast Cancer Recurrence

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1998
Primary Completion Date:   November 2002 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer.
  • Determine the impact of sociodemographic, clinical, and psychosocial predictors of well-being in these patients.
  • Determine the changes in well-being over time since disease recurrence in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), time since initial diagnosis (less than 2 years vs 2 years or more), and recurrence site (soft tissue without bone vs soft tissue with bone vs visceral). Patients are randomized to one of two study arms.

  • Arm I (control arm): Patients receive the standard level of support by continuing to use existing resources. Patients receive written materials from the counseling group at 6 months.
  • Arm II (intervention arm): Patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions. Patients receive written materials from the counseling group after the first session.

In both arms, quality of life is assessed at baseline and at 3 and 6 months.

PROJECTED ACCRUAL: A total of 300 patients (150 per study arm) will be accrued for this study within 30 months.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Received prior definitive surgical treatment for stage I-IIIa breast cancer with or without adjuvant chemotherapy, hormonal therapy, and/or radiotherapy
  • No more than 56 days since diagnosis of first recurrence

    • Any distant metastatic site, chest wall recurrence, scar recurrence, or nodal recurrence
    • No ipsilateral breast tumor recurrence after lumpectomy or isolated contralateral new primary breast tumors
  • Receiving or planning to receive first therapy for recurrence

    • No prior therapy for this recurrence except surgical treatment for in-breast relapse after lumpectomy or local palliative radiotherapy
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No psychiatric diagnosis that would preclude study
  • Must be able to read and understand English

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031772

Show 109 study locations  Show 109 Study Locations

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Carolyn Gotay, PhD     University of Hawaii Cancer Research Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Gotay CC, Moinpour CM, Unger JM, Jiang CS, Coleman D, Martino S, Parker BJ, Bearden JD, Dakhil S, Gross HM, Lippman S, Albain KS. Impact of a peer-delivered telephone intervention for women experiencing a breast cancer recurrence. J Clin Oncol. 2007 May 20;25(15):2093-9.
 
Gotay CC, Moinpour CM, Jiang CS, et al.: Enhancing well-being during breast cancer recurrence: preliminary findings from a phase III study. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-3080, 2004.
 

Study ID Numbers:   CDR0000069225, SWOG-S9832, NCI-P02-0209
First Received:   March 8, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00031772
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer  
psychosocial effects/treatment  
quality of life  

Study placed in the following topic categories:
Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008




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