Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

This study has been terminated.
(Proposal will not be submitted and low accrual.)
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01628887
First received: June 25, 2012
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI) [ Time Frame: 2 months after completion of the educational session ] [ Designated as safety issue: No ]
    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 cultural and linguistic appropriateness of the BBCEI [ Time Frame: 2 months after completion of the educational session ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months after completion of the educational session ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 months after completion of the educational session ] [ Designated as safety issue: No ]
    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


Enrollment: 4
Study Start Date: August 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628887

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

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01628887     History of Changes
Other Study ID Numbers: 12175
Study First Received: June 25, 2012
Last Updated: July 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014