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

NCT ID: NCT00932997

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2010-06-30

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

telephone-based intervention

Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

Intervention Type: BEHAVIORAL

counseling intervention

Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

Intervention Type: OTHER

educational intervention

Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey

Intervention Type: OTHER

questionnaire administration

Baseline and 9 months after enrollment and intervention

Intervention Type: OTHER

psychosocial assessment and care

Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey

Intervention Type: PROCEDURE

quality-of-life assessment

Baseline and 9 months after enrollment and intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimlin Ashing-Giwa, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Comprehensive Cancer Center

Locations

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Countries

United States

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-06102

Identifier Type: -

Identifier Source: secondary_id

CDR0000642414

Identifier Type: REGISTRY

Identifier Source: secondary_id

06102

Identifier Type: -

Identifier Source: org_study_id