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Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

Primary Purpose

Cancer Survivor, Stage I Breast Cancer, Stage II Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor focused on measuring Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (BBCEI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2012
Last Updated
July 12, 2013
Sponsor
City of Hope Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01628887
Brief Title
Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
Official Title
Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Proposal will not be submitted and low accrual.
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (BBCEI)
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
Undergo Bilingual Breast Cancer Educational Intervention
Primary Outcome Measure Information:
Title
Determine the feasibility of implementation of a Bilingual Breast Cancer Education Intervention (BBCEI)
Description
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.
Time Frame
2 months after completion of the educational session
Title
Determine the cultural and linguistic appropriateness of the BBCEI
Description
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
Time Frame
2 months after completion of the educational session
Title
Determine topics requiring further emphasis in the BBCEI
Description
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
Time Frame
2 months after completion of the educational session
Title
Determine ways to enhance program content, format and materials
Description
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
Time Frame
2 months after completion of the educational session

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Juarez, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility of a Supportive Education Program for Latina Breast Cancer Survivors

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