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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

June 25, 2012
July 12, 2013
August 2012
July 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01628887 on ClinicalTrials.gov Archive Site
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Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • 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
Undergo Bilingual Breast Cancer Educational Intervention
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.
Intervention: Other: Educational Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01628887
12175
Yes
City of Hope Medical Center
City of Hope Medical Center
Not Provided
Principal Investigator: Gloria Juarez, PhD City of Hope Medical Center
City of Hope Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP