Patient Centered Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Early-Stage Breast Cancer
• Interventions: Behavioral: Patient Assistance; Behavioral: Information only

• Registration Number: NCT00233077
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed 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

Study Timeline

• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Study Start: 2006-10
• Primary Completion: 2010-06
• Study Completion: 2011-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-02
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 374

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: Patient Assistance	Patient Assistance	Patient assistance programs
Control: Information only	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.

Primary Outcome Measures

Name	Time	Method
initiation and completion of primary treatment	Measured after completion of 6-mth interview

Secondary Outcome Measures

Name	Time	Method
emotional and health status	Measured after completion of 6-mth interview
patient satisfaction	Measured after completion of 6-mth interview
adherence	Measured after completion of 6-mth interview

Trial Locations

Locations (8)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Metropolitan Hospital; 🇺🇸 New York, New York, United States

Queens Hospital Center; 🇺🇸 Queens, New York, United States

Harlem Hospital Center; 🇺🇸 New York, New York, United States

Albert Einstein College of Medicine; 🇺🇸 New York, New York, United States

Elmhurst Hospital Center; 🇺🇸 Queens, New York, United States

Columbia University; 🇺🇸 New York, New York, United States

Montefiore Medical Center; 🇺🇸 New York, New York, United States