Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00932997
First received: July 3, 2009
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.

PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.


Condition Intervention
Breast Cancer
Cancer Survivor
Psychosocial Effects of Cancer and Its Treatment
Behavioral: telephone-based intervention
Other: counseling intervention
Other: educational intervention
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Reducing the Burden of Breast Cancer Among African American and Latina Survivors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Increased knowledge about the psychological and physical impact of breast cancer [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]
  • Improved psychological functioning (depression and anxiety) [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]
  • Improved family and social functioning (changes in family and partner communications) [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) [ Time Frame: 9 months post study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2006
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: telephone-based intervention
    Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey
    Other: counseling intervention
    Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey
    Other: educational intervention
    Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey
    Other: questionnaire administration
    Baseline and 9 months after enrollment and intervention
    Procedure: psychosocial assessment and care
    Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey
    Procedure: quality-of-life assessment
    Baseline and 9 months after enrollment and intervention
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.
  • Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.
  • Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.

Secondary

  • Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.

OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups.

  • Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.
  • Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1.

After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with breast cancer within the past 1-5 years

    • Stage I-IIIA disease
  • No metastatic disease

PATIENT CHARACTERISTICS:

  • No other major disabling medical (e.g., another cancer, stroke, heart disease) or psychiatric conditions
  • Self-identified ethnically as African-American or Latina
  • Able to read and/or speak English or Spanish
  • No severe depression or anxiety

    • History of mild to moderate depression or anxiety allowed
  • Not pregnant
  • Not incarcerated

PRIOR CONCURRENT THERAPY:

  • Any type of prior anticancer therapy allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932997

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Kimlin Ashing-Giwa, PhD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Kimlin Ashing-Giwa, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00932997     History of Changes
Other Study ID Numbers: 06102, P30CA033572, CHNMC-06102, CDR0000642414
Study First Received: July 3, 2009
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
cancer survivor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014