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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-06102 | |||
| CDR0000642414 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.
After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telephone-based intervention | Behavioral | Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey | ||
| counseling intervention | Other | Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey | ||
| educational intervention | Other | Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey | ||
| questionnaire administration | Other | Baseline and 9 months after enrollment and intervention | ||
| psychosocial assessment and care | Procedure | Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey |
| Measure | Description | Time Frame |
|---|---|---|
| Increased knowledge about the psychological and physical impact of breast cancer | 9 months post study enrollment | |
| Improved psychological functioning (depression and anxiety) | 9 months post study enrollment | |
| Improved family and social functioning (changes in family and partner communications) | 9 months post study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) | 9 months post study enrollment |
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DISEASE CHARACTERISTICS:
Diagnosed with breast cancer within the past 1-5 years
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
Not pregnant
Not incarcerated
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Kimlin Ashing-Giwa, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| quality-of-life assessment | Procedure | Baseline and 9 months after enrollment and intervention |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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