Patient Centered Randomized Controlled Trial
Patient Assistance to Reduce Breast Cancer Disparities
2 other identifiers
interventional
374
1 country
8
Brief Summary
The purpose of this study is to determine whether patient-assistance programs as compared with usual care will help women with early stage breast cancer receive appropriate treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedDecember 3, 2013
December 1, 2013
3.7 years
October 3, 2005
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
initiation and completion of primary treatment
Measured after completion of 6-mth interview
Secondary Outcomes (5)
adherence
Measured after completion of 6-mth interview
emotional and health status
Measured at baseline
emotional and health status
Measured after completion of 6-mth interview
patient satisfaction
measured at baseline
patient satisfaction
Measured after completion of 6-mth interview
Study Arms (2)
Behavioral: Patient Assistance
EXPERIMENTALPatient assistance programs
Control: Information only
OTHERControl patients will be sent a pamphlet about breast cancer \& its treatment. We will call all patients 2 weeks later and ask if they received the packet. If they didn't, we will send the packet again.
Interventions
Patients will be surveyed to assess their knowledge about cancer \& its treatment, experience with \& access to health care system, trust, depression, social support \& self-efficacy. A Brief Screening Needs Assessment will be done to ascertain practical, informational or psychosocial needs; based on their responses, an individualized action plan to connect with patient assistance programs will be created for the intervention group. We will ask intervention patients if they connected with any programs in their action plan. For those who didn't connect, we will give their name to an outreach worker. The outreach worker will call patients and identify reasons for not contacting the assistance programs.
Control patients will be sent a pamphlet about breast cancer \& its treatment. We will call all patients 2 weeks later and ask if they received the packet. If they didn't, we will send the packet again.
Eligibility Criteria
You may qualify if:
- All patients, who are English or Spanish speaking, with a new primary stage 1 or 2 breast cancer who have undergone either breast conserving surgery or mastectomy and those with tumors \>1cm or \<1cm and poorly differentiated;
- All surgeons performing breast surgery at the participating hospitals
You may not qualify if:
- Patients with dementia or those with a poor prognosis due to end-stage organ failure or other concomitant conditions such as those undergoing treatment for other cancers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Metropolitan Hospital
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Harlem Hospital Center
New York, New York, 10037, United States
Albert Einstein College of Medicine
New York, New York, 10461, United States
Montefiore Medical Center
New York, New York, 10467, United States
Elmhurst Hospital Center
Queens, New York, 11373, United States
Queens Hospital Center
Queens, New York, 11432, United States
Related Publications (3)
Guth AA, Fineberg S, Fei K, Franco R, Bickell NA. Utilization of Oncotype DX in an Inner City Population: Race or Place? Int J Breast Cancer. 2013;2013:653805. doi: 10.1155/2013/653805. Epub 2013 Dec 18.
PMID: 24455283DERIVEDBickell NA, Geduld AN, Joseph KA, Sparano JA, Kemeny MM, Oluwole S, Menes T, Srinivasan A, Franco R, Fei K, Leventhal H. Do community-based patient assistance programs affect the treatment and well-being of patients with breast cancer? J Oncol Pract. 2014 Jan;10(1):48-54. doi: 10.1200/JOP.2013.000920. Epub 2013 Sep 10.
PMID: 24023271DERIVEDLin JJ, Fei K, Franco R, Bickell NA. Breast cancer patients' recall of receiving patient assistance services. Springerplus. 2012 Oct 3;1:24. doi: 10.1186/2193-1801-1-24. eCollection 2012.
PMID: 23961354DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nina A Bickell, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
October 1, 2006
Primary Completion
June 1, 2010
Study Completion
January 1, 2011
Last Updated
December 3, 2013
Record last verified: 2013-12