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Completed

NCT Number: NCT00932997

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Telephone-Based Intervention

Behavioral

Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

counseling intervention

Other

Participants receive a "Survivorship Kit" and telephone sessions based upon responses to initial survey

Educational Intervention

Other

Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey

Questionnaire Administration

Other

Baseline and 9 months after enrollment and intervention

psychosocial assessment and care

Procedure

Participants receive a "Survivorship Kit" alone or in combination with telephone sessions based upon responses to initial survey

quality-of-life assessment

Procedure

Baseline and 9 months after enrollment and intervention

Primary outcomes

  1. Increased knowledge about the psychological and physical impact of breast cancer

    Time frame: 9 months post study enrollment

  2. Improved psychological functioning (depression and anxiety)

    Time frame: 9 months post study enrollment

  3. Improved family and social functioning (changes in family and partner communications)

    Time frame: 9 months post study enrollment

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Reducing the Burden of Breast Cancer Among African American and Latina Survivors

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2009
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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