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

Breast Cancer Clinical Trial

Official title:

Reducing the Burden of Breast Cancer Among African American and Latina Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932997
• Other study ID #: 06102
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: July 3, 2009
• Last updated: June 3, 2015
• Start date: October 2006
• Est. completion date: June 2010

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Behavioral:
• telephone-based intervention
Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

Other:
• counseling intervention
Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey
• educational intervention
Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey
• questionnaire administration
Baseline and 9 months after enrollment and intervention

Procedure:
• psychosocial assessment and care
Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey
• quality-of-life assessment
Baseline and 9 months after enrollment and intervention

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased knowledge about the psychological and physical impact of breast cancer		9 months post study enrollment	No
Primary	Improved psychological functioning (depression and anxiety)		9 months post study enrollment	No
Primary	Improved family and social functioning (changes in family and partner communications)		9 months post study enrollment	No
Secondary	Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors)		9 months post study enrollment	No