Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Sponsor
City of Hope Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01628887
Collaborator
(none)
4
1
1
11
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Study Details

Study Description

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
  • Other: Educational Intervention
N/A

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

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
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 :
Aug 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

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

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01628887
Other Study ID Numbers:
  • 12175
First Posted:
Jun 27, 2012
Last Update Posted:
Jul 16, 2013
Last Verified:
Jul 1, 2013
Keywords provided by City of Hope Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2013