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CompletedNCT01043003Updated Jun 8, 2015

Bilingual Breast Cancer Educational Intervention for Hispanic Women With Stage I, Stage II, or Stage III Breast Cancer and Their Families or Caregivers

An interventional study of educational intervention and quality-of-life assessment in Breast Cancer, Ductal Breast Carcinoma in Situ and Stage I Breast Cancer, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-08.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

OBJECTIVES:

I. Test the effects of the Bilingual Breast Cancer Education Intervention (BBCEI) on outcomes of breast cancer survivors (BCS) and family caregivers at 1, 3, and 6 months post intervention.

II. Test the effect of influencing demographic and treatment variables on outcomes of the BBCEI at 1, 3, and 6 months post intervention.

III. Examine the perceived quality of the BBCEI.

OUTLINE: Patients and caregivers are randomized to 1 of 2 intervention arms.

ARM I: 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.

ARM II: 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.

All patients and caregivers receive reinforcement telephone calls every other week.

02

Conditions studied

  • Breast Cancer
  • Ductal Breast Carcinoma in Situ
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 49 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 182 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Arm I

    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 intervention · Procedure: quality-of-life assessment · Other: Questionnaire Administration · Other: psychosocial support for caregiver · Procedure: assessment of therapy complications · Other: informational intervention

  • Active comparator
    Arm II

    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 assessment · Other: Questionnaire Administration · Other: psychosocial support for caregiver · Procedure: assessment of therapy complications · Other: informational intervention

Interventions

  • Othereducational intervention

    Undergo Bilingual Breast Cancer Educational Intervention

    Also known as: intervention, educational

  • Procedurequality-of-life assessment

    Ancillary studies

    Also known as: quality of life assessment

  • OtherQuestionnaire Administration

    Ancillary studies

  • Otherpsychosocial support for caregiver

    Support for caregiver

  • Procedureassessment of therapy complications

    Ancillary study

  • Otherinformational intervention

    Undergo evaluation sessions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At 1, 3, and 6 months post intervention

  2. Effect of influencing demographic and treatment variables on outcomes of the BBCEI

    Time frame: At 1, 3, and 6 months post intervention

  3. Perceived quality of the BBCEI

    Time frame: At 1, 3, and 6 months post intervention

07

Study locations

1 site
  • City of Hope
    Duarte, California 91010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01043003
Lead sponsor
City of Hope Medical Center
Responsible party
Sponsor
First posted
Jan 6, 2010
Start date
Aug 2006
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jun 8, 2015

Study contacts

Gloria Juarez
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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