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Support for Hispanic Breast Cancer Patients and Caregivers


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, 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

Thank you

Trial Information

Support for Hispanic Breast Cancer Patients and Caregivers


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

At 1, 3, and 6 months post intervention

Safety Issue:

No

Principal Investigator

Gloria Juarez

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

06136

NCT ID:

NCT01043003

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast

Name

Location

City of Hope Duarte, California  91010