NCT00932997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

3.7 years

First QC Date

July 3, 2009

Last Update Submit

June 3, 2015

Conditions

Breast CancerCancer SurvivorPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentstage I breast cancerstage II breast cancerstage IIIA breast cancercancer survivor

Outcome Measures

Primary Outcomes (3)

  • Increased knowledge about the psychological and physical impact of breast cancer

    9 months post study enrollment

  • Improved psychological functioning (depression and anxiety)

    9 months post study enrollment

  • Improved family and social functioning (changes in family and partner communications)

    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)

    9 months post study enrollment

Interventions

telephone-based interventionBEHAVIORAL

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

counseling interventionOTHER

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

educational interventionOTHER

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

questionnaire administrationOTHER

Baseline and 9 months after enrollment and intervention

psychosocial assessment and carePROCEDURE

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

quality-of-life assessmentPROCEDURE

Baseline and 9 months after enrollment and intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CounselingEarly Intervention, EducationalPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health ServicesRehabilitationTherapeutics

Study Officials

  • Kimlin Ashing-Giwa, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 7, 2009

Study Start

October 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)