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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Cancer Survivor Psychosocial Effects of Cancer and Its Treatment |
Behavioral: telephone-based intervention Other: counseling intervention Other: educational intervention Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Reducing the Burden of Breast Cancer Among African American and Latina Survivors |
- Increased knowledge about the psychological and physical impact of breast cancer [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]
- Improved psychological functioning (depression and anxiety) [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]
- Improved family and social functioning (changes in family and partner communications) [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]
- Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2006 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
-
Behavioral: telephone-based intervention
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Principal Investigator: | Kimlin Ashing-Giwa, PhD | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kimlin Ashing-Giwa, City of Hope Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00932997 History of Changes |
| Other Study ID Numbers: | 06102, P30CA033572, CHNMC-06102, CDR0000642414 |
| Study First Received: | July 3, 2009 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
psychosocial effects of cancer and its treatment stage I breast cancer stage II breast cancer stage IIIA breast cancer cancer survivor |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013