Clinical trial 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
Official title: Reducing the Burden of Breast Cancer Among African American and Latina Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer Survivor
Psychosocial Effects of Cancer and Its Treatment
Keywords: psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
cancer survivor
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 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.

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 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

Primary outcomes:
measure: Increased knowledge about the psychological and physical impact of breast cancer
timeFrame: 9 months post study enrollment
measure: Improved psychological functioning (depression and anxiety)
timeFrame: 9 months post study enrollment
measure: Improved family and social functioning (changes in family and partner communications)
timeFrame: 9 months post study enrollment
Secondary outcomes:
measure: Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors)
timeFrame: 9 months post study enrollment
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Kimlin Ashing-Giwa, PhD
role: PRINCIPAL_INVESTIGATOR
References: