Bilingual Breast Cancer Educational Intervention for Hispanic Women With Stage I, Stage II, or Stage III Breast Cancer and Their Families or Caregivers
NCT ID: NCT01043003
Last Updated: 2015-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2006-08-31
2011-11-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well an educational intervention works in supporting Hispanic women with stage I, stage II, or stage III breast cancer and their families or caregivers.
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Detailed Description
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I. Test the effects of the Bilingual Breast Cancer Education Intervention (BBCEI) on outcomes of breast cancer survivors (BCS) and family caregivers at 1, 3, and 6 months post intervention.
II. Test the effect of influencing demographic and treatment variables on outcomes of the BBCEI at 1, 3, and 6 months post intervention.
III. Examine the perceived quality of the BBCEI.
OUTLINE: Patients and caregivers are randomized to 1 of 2 intervention arms.
ARM I: Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7.
ARM II: Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7.
All patients and caregivers receive reinforcement telephone calls every other week.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I
Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7. Patients and caregivers receive reinforcement telephone calls every other week.
educational intervention
Undergo Bilingual Breast Cancer Educational Intervention
quality-of-life assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
psychosocial support for caregiver
Support for caregiver
assessment of therapy complications
Ancillary study
informational intervention
Undergo evaluation sessions
Arm II
Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7. Patients and caregivers receive reinforcement telephone calls every other week.
quality-of-life assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
psychosocial support for caregiver
Support for caregiver
assessment of therapy complications
Ancillary study
informational intervention
Undergo evaluation sessions
Interventions
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educational intervention
Undergo Bilingual Breast Cancer Educational Intervention
quality-of-life assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
psychosocial support for caregiver
Support for caregiver
assessment of therapy complications
Ancillary study
informational intervention
Undergo evaluation sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No evidence of recurrent, metastatic, or second primary cancer
* Completing primary treatment with surgery, radiation therapy (if indicated), and/or adjuvant chemotherapy (if indicated)
* Subjects may be on hormonal therapy after treatment for initial breast cancer
* Self-identification as Hispanic/Latino
* Able to read and understand English or Spanish to participate in the patient teaching
* Able and willing to participate in the study
* The Caregiver selection criteria is: self-identification as the primary caregiver; age 18 years or over; self-identification as Hispanic/Latino; Able to read and speak English or Spanish; Able and willing to participate in the study
Exclusion
* Patients will be excluded if they are actively receiving treatment with surgery, radiation therapy, or chemotherapy; patients may be receiving adjuvant hormonal therapy such as Tamoxifen during the course of the study since it is recommended for five years after primary and adjuvant therapy
* Patients who have recurrence, metastasis, or a second primary cancer will not be recruited for the study; if however, they develop recurrence, metastasis, or a second primary cancer during the time of the study participation, the subjects will remain in the study
* Patients will not be recruited directly from support groups because of potential bias inherent in sample attending support groups; however, some patients may be participating in support groups or other forms of counseling
18 Years
FEMALE
Yes
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Gloria Juarez
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2009-01548
Identifier Type: -
Identifier Source: secondary_id
06136
Identifier Type: -
Identifier Source: org_study_id
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