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Completed

NCT Number: NCT01043003

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion

  • 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

  • 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

Treatment and study plan

Educational Intervention

Other

Undergo Bilingual Breast Cancer Educational Intervention

Other names: intervention, educational

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

Psychosocial Support for Caregiver

Other

Support for caregiver

assessment of therapy complications

Procedure

Ancillary study

Informational intervention

Other

Undergo evaluation sessions

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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

Support for Hispanic Breast Cancer Patients and Caregivers

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 6, 2010
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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