S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00031772
First received: March 8, 2002
Last updated: February 12, 2013
Last verified: February 2013

March 8, 2002
February 12, 2013
July 1998
November 2003   (final data collection date for primary outcome measure)
Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00031772 on ClinicalTrials.gov Archive Site
  • Examine impact of sociodemographic, clinical, and psychosocial predictors of well-being in patients experiencing a first recurrence of breast cancer. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Examine changes in well-being over time since recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
S9832: Effectiveness of Telephone Counseling By Breast Cancer Survivors on the Well-Being of Women With Recurrent Breast Cancer
Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Breast Cancer
  • Psychosocial Effects of Cancer and Its Treatment
Procedure: psychosocial assessment and care
Questionnaire and telephone intervention
  • No Intervention: Control
    Standard level of support after recurrence diagnosis
  • Experimental: Intervention
    Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
    Intervention: Procedure: psychosocial assessment and care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
November 2003
November 2003   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00031772
CDR0000069225, S9832, NCI-P02-0209, U10CA037429
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Carolyn Gotay, PhD University of Hawaii Cancer Research Center
Southwest Oncology Group
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP