Bilingual Breast Cancer Educational Intervention for Hispanic Women With Stage I, Stage II, or Stage III Breast Cancer and Their Families or Caregivers

Breast Cancer Clinical Trial

Official title:

Support for Hispanic Breast Cancer Patients and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043003
• Other study ID #: 06136
• Secondary ID: NCI-2009-01548
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: June 3, 2015
• Start date: August 2006
• Est. completion date: November 2011

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: Studying quality-of-life in patients having cancer treatment may identify the intermediate- and long-term effects of treatment on patients with cancer

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.

Description:

OBJECTIVES:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion

• Histologically confirmed diagnosis of stage 0 (DCIS), I, II, or III breast cancer

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Breast Carcinoma in Situ
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Intervention

Other:
• educational intervention
Undergo Bilingual Breast Cancer Educational Intervention

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• Questionnaire Administration
Ancillary studies
• psychosocial support for caregiver
Support for caregiver

Procedure:
• assessment of therapy complications
Ancillary study

Other:
• informational intervention
Undergo evaluation sessions

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of the Bilingual Breast Cancer Education Intervention on outcomes (physical, psychological, social, spiritual, and overall quality of life) of breast cancer survivor and family caregivers		At 1, 3, and 6 months post intervention	No
Primary	Effect of influencing demographic and treatment variables on outcomes of the BBCEI		At 1, 3, and 6 months post intervention	No
Primary	Perceived quality of the BBCEI		At 1, 3, and 6 months post intervention	No