Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors

City of Hope

Status: Completed

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

Treatments: Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Other: counseling intervention; Other: questionnaire administration; Other: educational intervention; Behavioral: telephone-based intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00932997

CDR0000642414 (Registry Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

06102

CHNMC-06102

Details and patient eligibility

About

RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.

PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.

Full description

OBJECTIVES:

Primary

• Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.
• Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.
• Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.

Secondary

• Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.

OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.

• Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.
• Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1.

After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosed with breast cancer within the past 1-5 years

  • Stage I-IIIA disease

• No metastatic disease

PATIENT CHARACTERISTICS:

• No other major disabling medical (e.g., another cancer, stroke, heart disease) or psychiatric conditions

• Self-identified ethnically as African-American or Latina

• Able to read and/or speak English or Spanish

• No severe depression or anxiety

  • History of mild to moderate depression or anxiety allowed

• Not pregnant

• Not incarcerated

PRIOR CONCURRENT THERAPY:

• Any type of prior anticancer therapy allowed