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

Primary Purpose

Breast Cancer, Ductal Breast Carcinoma in Situ, Stage I Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

educational intervention

quality-of-life assessment

Questionnaire Administration

psychosocial support for caregiver

assessment of therapy complications

informational intervention

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

City of Hope

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Effect of influencing demographic and treatment variables on outcomes of the BBCEI

Perceived quality of the BBCEI

Secondary Outcome Measures

Full Information

NCT ID

NCT01043003

First Posted

January 4, 2010

Last Updated

June 3, 2015

Sponsor

City of Hope Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01043003

Brief Title

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

Official Title

Support for Hispanic Breast Cancer Patients and Caregivers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Arm Title

Arm II

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

educational intervention

Other Intervention Name(s)

intervention, educational

Intervention Description

Undergo Bilingual Breast Cancer Educational Intervention

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

psychosocial support for caregiver

Intervention Description

Support for caregiver

Intervention Type

Procedure

Intervention Name(s)

assessment of therapy complications

Intervention Description

Ancillary study

Intervention Type

Other

Intervention Name(s)

informational intervention

Intervention Description

Undergo evaluation sessions

Primary Outcome Measure Information:

Title

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

Time Frame

At 1, 3, and 6 months post intervention

Title

Effect of influencing demographic and treatment variables on outcomes of the BBCEI

Time Frame

At 1, 3, and 6 months post intervention

Title

Perceived quality of the BBCEI

Time Frame

At 1, 3, and 6 months post intervention

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gloria Juarez

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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