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

June 3, 2015 updated by: City of Hope Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increased knowledge about the psychological and physical impact of breast cancer Time Frame: 9 months post study enrollment	9 months post study enrollment
Improved psychological functioning (depression and anxiety) Time Frame: 9 months post study enrollment	9 months post study enrollment
Improved family and social functioning (changes in family and partner communications) Time Frame: 9 months post study enrollment	9 months post study enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
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	9 months post study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)