Patient Centered Randomized Controlled Trial

Early-Stage Breast Cancer Clinical Trial

Official title:

Patient Assistance to Reduce Breast Cancer Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233077
• Other study ID #: GCO 03-0593
• Secondary ID: 1R01CA10705-01A1
• Status: Completed
• Phase: N/A
• First received: October 3, 2005
• Last updated: December 2, 2013
• Start date: October 2006
• Est. completion date: January 2011

Study information

• Verified date: December 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Numerous trials proved the efficacy of radiation following breast conserving surgery and systemic therapies to increase disease-free and overall survival among women with early-stage breast cancer. Yet 14%-89% of women do not receive them, especially minority women. Despite lower incidence of the disease, African American women are more likely than white women to die of breast cancer. As we near racial equity in rates of breast cancer screening, disparities in treatment and mortality remain. Efforts to achieve control of breast cancer and reduce racial disparities in mortality will not be fully realized until proven effective treatments are provided to those who can benefit.

Underuse of effective treatments may be caused by patient, physician and system factors. For breast cancer screening, women's lack of access to care; insurance; transportation; beliefs about fatalism and curability, and cancer's effect on partner relationships, all impact mammography rates. For breast cancer treatment, little is known about patient-related reasons for underuse, and less is known about racial differences in such reasons.

Interventions targeted to specific causes are more likely to succeed. For breast cancer screening, patient-centered interventions that successfully raise mammography rates among minority women include lay health workers to raise awareness about and address cultural beliefs and barriers to screening, vouchers to pay for screening and navigators to help women with abnormal screenings obtain needed follow-up. For breast cancer treatment, patient-assistance programs provide practical support such as financial counseling, aid with navigating the complex healthcare system, emotional support, and information about cancer and its treatment. Such programs abound but patients are often unaware of them. While these services may increase the receipt of effective adjuvant therapies, these strategies have not been rigorously tested.

We propose to conduct a randomized controlled trial to evaluate the effectiveness of patient-assistance programs as compared with usual care on receipt of adjuvant therapies among minority and nonminority women with newly operated early-stage breast cancer. During the 24 month trial, we will assess patients' beliefs about cancer and its treatment, and their practical, psychosocial, and informational needs and barriers to care. We will identify and train employees in existing cancer assistance services in order to increase the sustainability of this program beyond the grant-funded cycle. Specifically, we propose:

1. To assess racial differences in early-stage breast cancer patients' experiences, beliefs about and barriers to effective adjuvant treatments;

2. To evaluate the effectiveness of an intervention connecting women with early-stage breast cancer and cancer-related needs to community and hospital-based patient-assistance programs to reduce underuse of effective adjuvant breast cancer treatment overall and in minority populations and to assess its sustainability; and

3. To evaluate whether this patient assistance intervention affects patients' knowledge, attitudes and behaviors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: January 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-Stage Breast Cancer

Intervention

Behavioral:
• Patient Assistance
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.
• Information only
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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	New York	New York
United States	Columbia University	New York	New York
United States	Harlem Hospital Center	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Metropolitan Hospital	New York	New York
United States	Montefiore Medical Center	New York	New York
United States	Elmhurst Hospital Center	Queens	New York
United States	Queens Hospital Center	Queens	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	initiation and completion of primary treatment		Measured after completion of 6-mth interview	No
Secondary	adherence		Measured after completion of 6-mth interview	No
Secondary	emotional and health status		Measured at baseline	No
Secondary	emotional and health status		Measured after completion of 6-mth interview	No
Secondary	patient satisfaction		measured at baseline	No
Secondary	patient satisfaction		Measured after completion of 6-mth interview	No