NCT01043003

Brief Summary

RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the intermediate- and long-term effects of treatment on patients with cancer PURPOSE: This randomized clinical trial is studying how well an educational intervention works in supporting Hispanic women with stage I, stage II, or stage III breast cancer and their families or caregivers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

5.3 years

First QC Date

January 4, 2010

Last Update Submit

June 3, 2015

Conditions

Breast CancerDuctal Breast Carcinoma in SituStage I Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • Effects of the Bilingual Breast Cancer Education Intervention on outcomes (physical, psychological, social, spiritual, and overall quality of life) of breast cancer survivor and family caregivers

    At 1, 3, and 6 months post intervention

  • Effect of influencing demographic and treatment variables on outcomes of the BBCEI

    At 1, 3, and 6 months post intervention

  • Perceived quality of the BBCEI

    At 1, 3, and 6 months post intervention

Study Arms (2)

Arm I

EXPERIMENTAL

Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7. Patients and caregivers receive reinforcement telephone calls every other week.

Other: educational interventionProcedure: quality-of-life assessmentOther: Questionnaire AdministrationOther: psychosocial support for caregiverProcedure: assessment of therapy complicationsOther: informational intervention

Arm II

ACTIVE COMPARATOR

Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7. Patients and caregivers receive reinforcement telephone calls every other week.

Procedure: quality-of-life assessmentOther: Questionnaire AdministrationOther: psychosocial support for caregiverProcedure: assessment of therapy complicationsOther: informational intervention

Interventions

educational interventionOTHER

Undergo Bilingual Breast Cancer Educational Intervention

Also known as: intervention, educational
Arm I
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm IArm II
Questionnaire AdministrationOTHER

Ancillary studies

Arm IArm II
psychosocial support for caregiverOTHER

Support for caregiver

Arm IArm II
assessment of therapy complicationsPROCEDURE

Ancillary study

Arm IArm II
informational interventionOTHER

Undergo evaluation sessions

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of stage 0 (DCIS), I, II, or III breast cancer
  • No evidence of recurrent, metastatic, or second primary cancer
  • Completing primary treatment with surgery, radiation therapy (if indicated), and/or adjuvant chemotherapy (if indicated)
  • Subjects may be on hormonal therapy after treatment for initial breast cancer
  • Self-identification as Hispanic/Latino
  • Able to read and understand English or Spanish to participate in the patient teaching
  • Able and willing to participate in the study
  • The Caregiver selection criteria is: self-identification as the primary caregiver; age 18 years or over; self-identification as Hispanic/Latino; Able to read and speak English or Spanish; Able and willing to participate in the study

You may not qualify if:

  • Patients will be excluded if they are actively receiving treatment with surgery, radiation therapy, or chemotherapy; patients may be receiving adjuvant hormonal therapy such as Tamoxifen during the course of the study since it is recommended for five years after primary and adjuvant therapy
  • Patients who have recurrence, metastasis, or a second primary cancer will not be recruited for the study; if however, they develop recurrence, metastasis, or a second primary cancer during the time of the study participation, the subjects will remain in the study
  • Patients will not be recruited directly from support groups because of potential bias inherent in sample attending support groups; however, some patients may be participating in support groups or other forms of counseling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Early Intervention, EducationalMethodsPsychiatric RehabilitationCaregivers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative TechniquesRehabilitationTherapeuticsHealth Personnel

Study Officials

  • Gloria Juarez

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 6, 2010

Study Start

August 1, 2006

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)