Patient Centered Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00233077
First received: October 3, 2005
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Early-Stage Breast Cancer
Behavioral: Patient Assistance
Behavioral: Information only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Patient Assistance to Reduce Breast Cancer Disparities

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • initiation and completion of primary treatment [ Time Frame: Measured after completion of 6-mth interview ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence [ Time Frame: Measured after completion of 6-mth interview ] [ Designated as safety issue: No ]
  • emotional and health status [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
  • emotional and health status [ Time Frame: Measured after completion of 6-mth interview ] [ Designated as safety issue: No ]
  • patient satisfaction [ Time Frame: measured at baseline ] [ Designated as safety issue: No ]
  • patient satisfaction [ Time Frame: Measured after completion of 6-mth interview ] [ Designated as safety issue: No ]

Enrollment: 374
Study Start Date: October 2006
Study Completion Date: January 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral: Patient Assistance
Patient assistance programs
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.
Control: 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.
Behavioral: 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233077

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
Albert Einstein College of Medicine
New York, New York, United States, 10461
Harlem Hospital Center
New York, New York, United States, 10037
Metropolitan Hospital
New York, New York, United States, 10029
Montefiore Medical Center
New York, New York, United States, 10467
Queens Hospital Center
Queens, New York, United States, 11432
Elmhurst Hospital Center
Queens, New York, United States, 11373
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Nina A Bickell, MD Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00233077     History of Changes
Other Study ID Numbers: GCO 03-0593, 1R01CA10705-01A1
Study First Received: October 3, 2005
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
breast cancer
adjuvant treatment
racial disparities

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014