NCT00937989

Brief Summary

RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life. PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2.5 years

First QC Date

July 10, 2009

Last Update Submit

June 3, 2015

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situlobular breast carcinoma in situmale breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (3)

  • Barrier resolution (information, transportation, appointments, and communication) and time to resolution

    Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.

  • Quality of life (psychological, physical, social, and spiritual well-being)

    Prior to starting treatment and 3, 6 and 9 months after starting the study.

  • Navigation and care (patient's satisfaction and value, provider's perception of barriers)

    3, 6 and 9 months after starting the study.

Interventions

educational interventionOTHER

Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.

informational interventionOTHER

Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.

medical chart reviewOTHER

Baseline, 3, 6 and 9 months after starting the study

questionnaire administrationOTHER

Baseline, 3, 6 and 9 months after starting the study

study of socioeconomic and demographic variablesOTHER

Baseline, 3, 6 and 9 months after starting the study

quality-of-life assessmentPROCEDURE

Baseline, 3, 6 and 9 months after starting the study

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed breast cancer * Stage 0-III disease * No metastasis or recurrent disease * Insured with Medi-Cal OR ≥ 65 years old * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * English or Spanish-speaking * Intending to receive all primary breast cancer treatment at City of Hope PRIOR CONCURRENT THERAPY: * No prior therapy for breast cancer

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 NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In SituBreast Neoplasms, Male

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Rebecca Crane-Okada, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

November 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

US(1)