Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Stage IIIA Breast Cancer Clinical Trial

Official title:

Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01628887
• Other study ID #: 12175
• Status: Terminated
• Phase: N/A
• First received: June 25, 2012
• Last updated: July 12, 2013
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• 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

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Survivor
• 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

Locations

Country	Name	City	State
United States	City of Hope Medical Center	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	Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI)	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 months after completion of the educational session	No
Primary	Determine the cultural and linguistic appropriateness of the BBCEI	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 months after completion of the educational session	No
Primary	Determine topics requiring further emphasis in the BBCEI	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 months after completion of the educational session	No
Primary	Determine ways to enhance program content, format and materials	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 months after completion of the educational session	No