Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

NCT01628887 | Terminated DMC

• 1 other identifier: 12175
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer Survivor; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Supportive Care (BBCEI)

EXPERIMENTAL

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

Interventions

Educational Intervention OTHER

Undergo Bilingual Breast Cancer Educational Intervention

Supportive Care (BBCEI)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Gloria Juarez, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 27, 2012
• Study Start: August 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

US (1)