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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
  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 of Cancer and Its Treatment
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 322
Study Start Date: July 1998
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: psychosocial assessment and care
Questionnaire and telephone intervention

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

Ages Eligible for Study:   18 Years and older
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
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: NCT00031772

  Show 109 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Carolyn Gotay, PhD University of Hawaii Cancer Research Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00031772     History of Changes
Other Study ID Numbers: CDR0000069225, S9832, NCI-P02-0209, U10CA037429
Study First Received: March 8, 2002
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
recurrent breast cancer
psychosocial effects of cancer and its treatment

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

ClinicalTrials.gov processed this record on November 19, 2014