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Study of Economic Circumstances, Service Utilization, and Service Needs Among Older Colon Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
State University of New York - Downstate Medical Center
Ralph Lauren Center for Cancer Care and Prevention
Albert Einstein College of Medicine of Yeshiva University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00774839
First received: October 16, 2008
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to learn more about the social and financial impact of colon cancer for older patients. We want to know how cancer has affected the patient financially and socially, and to know if the patient has resource needs that have gone unmet. By doing this study, we hope to learn about resources that can reduce the financial burden from cancer.


Condition Intervention
Colon Cancer
Behavioral: Patient Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Economic Circumstances, Service Utilization, and Service Needs Among Older Colon Cancer Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Self-reported expenses associated with colon cancer treatment and living with this illness. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The perceived impact of cancer on patients' overall financial and social well-being. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • The awareness of cancer support organizations and their utilization of informal and formal supports during treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • The patients' unmet resource and service needs during treatment. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • Identify the medical, social and economic risk factors that are most closely associated with perceived adverse impact on financial and social well-being and unmet resource and service needs. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: October 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Newly diagnosed stage II-III colon cancer 65 years or older
Medicare-eligible (≥ or = to 65 years) patients diagnosed with stage II - III colon cancer, are at least 4 months into chemotherapy and up to 7 months post-chemotherapy.
Behavioral: Patient Interview
The patient will participate in a semistructured interview conducted by a trained staff member and designed to last approximately 45 minutes. All interviews will take place at least 4 months into or up to 7 months after the end of the treatment, if possible and will be scheduled to occur at the time of the chemotherapy infusion, or at another time at the care facility when it is convenient for the patient. If the patient is not scheduled or chooses not to be at the care facility within a time frame that fits the study parameters, the patient may opt to be interviewed at another location, including the patient's home.
Other Names:
  • The interview includes five major topic areas: 1) Demographics and Health; 2) Expenses;
  • 3) Utilization of Supports and Services; 4) Impact on Financial and Social Well-Being;
  • and 5) Unmet Resources/Service Needs.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We will be recruiting from eight sites of care that serve different populations, which will allow us to sample Medicare-eligible individuals with a range of income, insurance coverage and socio-demographic characteristics. These sites are: Memorial Sloan-Kettering Cancer Center (MSKCC); four MSKCC Network locations (Commack, Phelps,Mercy, and Basking Ridge); SUNY Downstate Medical Center;Ralph Lauren Cancer Center and Albert Einstein College of Medicine/Montefiore Medical Center

Criteria

Inclusion Criteria:

  • 65 years or older
  • Newly diagnosed stage II-III colon cancer
  • Receiving chemotherapy and at least 4-6 months into chemotherapy treatment, or have received chemotherapy and no more than 7 months post-treatment
  • Sufficient cognitive capacity as determined by investigator or consenting professional
  • Able to speak English or Spanish
  • Able to provide informed consent

Exclusion Criteria:

  • N/A
  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: NCT00774839

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
United States, New York
Downstate Medical Center
Brooklyn, New York, United States, 11203
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States, 11570
Memoral Sloan Kettering Cancer Center@Phelps
Sleepy Hollow, New York, United States
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
State University of New York - Downstate Medical Center
Ralph Lauren Center for Cancer Care and Prevention
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Elena Elkin, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00774839     History of Changes
Other Study ID Numbers: 08-124
Study First Received: October 16, 2008
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Newly Diagnosed
Colon
Stage II
Stage III

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014