Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Study Description

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Brief Summary:

This clinical trial studies a supportive education program for Latina breast cancer survivors. The Bilingual Breast Cancer Education Intervention (BBCEI) may help Latina breast cancer survivors know what to expect after completing breast cancer treatment and prepare them to cope with cancer related survivorship issues

Condition or disease	Intervention/treatment	Phase
Cancer Survivor; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer	Other: Educational Intervention	Not Applicable

Detailed Description:

PRIMARY OBJECTIVES: I. Describe the feasibility of implementing the BBCEI. II. Describe the cultural and linguistic appropriateness of the BBCEI. III. Determine topics requiring further emphasis in the BBCEI. IV. Identify ways to enhance program content, format, and materials. OUTLINE: Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
Study Start Date :	August 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Supportive Care (BBCEI); Participants undergo 2 tailored BBCEI sessions within 1 month. At the beginning of the first session the research nurse will present the participants with a list of common physical and social concerns. The participant will then be asked to identify 3 topics that she wants to discuss. The research nurse will discuss with the participant any relevant supportive care resources and make the appropriate referrals. At the second session the focus of the BBCEI will be on psychological and spiritual well-being.

Other: Educational Intervention; Undergo Bilingual Breast Cancer Educational Intervention

Outcome Measures

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Primary Outcome Measures :

1. Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI) [ Time Frame: 2 months after completion of the educational session ]
   A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials.
2. Determine the cultural and linguistic appropriateness of the BBCEI [ Time Frame: 2 months after completion of the educational session ]
   A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials
3. Determine topics requiring further emphasis in the BBCEI [ Time Frame: 2 months after completion of the educational session ]
   A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials
4. Determine ways to enhance program content, format and materials [ Time Frame: 2 months after completion of the educational session ]
   A semi-structured interview guide will be used to describe participant satisfaction with the BBCEI. It allows the patient to describe in their own words whether the BBCEI was effective for their QOL concerns, helpfulness of intervention content, describe the cultural and linguistic appropriateness and identify ways to enhance program content, format and materials

Eligibility Criteria

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

The population will consist of Latinas with breast cancer who have completed primary cancer treatment. A total of 10 subjects will be accrued.

Inclusion Criteria:

• Diagnosis of Stage I, II or III.
• Self-identification as Hispanic/Latina.
• Able to read and understand English or Spanish to participate in the education sessions.
• Ability to read and/or understand the study protocol requirements, and provide written informed consent
• Subjects maybe be on hormonal therapy after treatment for initial breast cancer.

Exclusion Criteria:

• Actively receiving treatment with surgery, radiation therapy, or chemotherapy.
• Patients who have recurrence, metastasis, or a second primary cancer

Contacts and Locations

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Locations

United States, California
City of Hope Medical Center
Duarte, California, United States, 91010

Sponsors and Collaborators

City of Hope Medical Center

Investigators

Principal Investigator:	Gloria Juarez, PhD	City of Hope Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT01628887 History of Changes
Other Study ID Numbers:	12175
First Posted:	June 27, 2012
Last Update Posted:	July 16, 2013
Last Verified:	July 2013

Keywords provided by City of Hope Medical Center:

Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases