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

SWOG Cancer Research Network

Status: Completed

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

Treatments: Procedure: psychosocial assessment and care

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00031772

CDR0000069225

S9832 (Other Identifier)

U10CA037429 (U.S. NIH Grant/Contract)

NCI-P02-0209 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 322 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

322 participants in 2 patient groups

Control

No Intervention group

Description:

Standard level of support after recurrence diagnosis

Intervention

Experimental group

Description:

Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.

Treatment:

Procedure: psychosocial assessment and care