Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Not Applicable

Terminated

• Conditions: Cancer Survivor; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
• Interventions: Other: Educational Intervention

• Registration Number: NCT01628887
• Lead Sponsor: City of Hope Medical Center

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

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 Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-27
• Study Start: 2012-08
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive Care (BBCEI)	Educational Intervention	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.

Primary Outcome Measures

Name	Time	Method
Determine the cultural and linguistic appropriateness of the BBCEI	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
Determine topics requiring further emphasis in the BBCEI	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
Determine ways to enhance program content, format and materials	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
Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI)	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States