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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer, Cancer Survivor, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Behavioral: telephone-based intervention
* Other: counseling intervention
* Other: educational intervention
* Other: questionnaire administration
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|
|Other: educational intervention|Participants receive a Survivorship Kit alone or in combination with telephone sessions based upon responses to initial survey|
|Other: 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|
|Procedure: quality-of-life assessment|Baseline and 9 months after enrollment and intervention|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, cancer survivor