Clinical trial NCT00233077: Patient Centered Randomized Controlled Trial
Official title: Patient Assistance to Reduce Breast Cancer Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-Stage Breast Cancer
Keywords: breast cancer
adjuvant treatment
racial disparities
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-05
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Eligibility criteria: 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

Primary outcomes:
measure: initiation and completion of primary treatment
timeFrame: Measured after completion of 6-mth interview
Secondary outcomes:
measure: adherence
timeFrame: Measured after completion of 6-mth interview
measure: emotional and health status
timeFrame: Measured at baseline
measure: emotional and health status
timeFrame: Measured after completion of 6-mth interview
measure: patient satisfaction
timeFrame: measured at baseline
measure: patient satisfaction
timeFrame: Measured after completion of 6-mth interview
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Metropolitan Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Harlem Hospital Center
state: New York
city: New York
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Queens
country: United States
facility: Elmhurst Hospital Center
state: New York
city: Queens
country: United States
facility: Queens Hospital Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nina A Bickell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bickell 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.
citation: Lin 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.