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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


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
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