Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05528263 - Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial) N/A
Completed NCT00165243 - Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer Phase 2
Recruiting NCT05559164 - Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Phase 2
Completed NCT03948568 - Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) Phase 4
Recruiting NCT04553770 - Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer Phase 2
Recruiting NCT06001762 - TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer Phase 2
Active, not recruiting NCT03664687 - Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL) Phase 4
Recruiting NCT04603209 - Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Recruiting NCT02958033 - Shandong Cancer Hospital Affiliated to Shandong University Phase 3
Recruiting NCT03788083 - Intratumoral TriMix Injections in Early Breast Cancer Patients Phase 1
Recruiting NCT03797248 - Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer
Recruiting NCT05582499 - Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy Phase 1/Phase 2
Recruiting NCT05871437 - Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer Phase 4
Recruiting NCT04003558 - Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)
Terminated NCT03894007 - Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer Phase 2
Recruiting NCT02982148 - Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients Phase 4
Active, not recruiting NCT03553797 - Accelerated Whole Breast Irradiation Hypofractionation Plus Boost VS Standard Whole Breast Irradiation Plus Boost Phase 3
Recruiting NCT06215469 - Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads) N/A
Enrolling by invitation NCT06409221 - VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Not yet recruiting NCT05280288 - Effect of the App Bone@BC Version 4.0 Under the Follow-up for Patients With Early Breast Cancer N/A