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

August 9, 2016 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memoral Sloan Kettering Cancer Center
    • New York
      • Brooklyn, New York, United States, 11203
        • Downstate Medical Center
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States
        • Ralph Lauren Center for Cancer Care and Prevention
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Cancer Center at Mercy Medical Center
      • Sleepy Hollow, New York, United States
        • Memoral Sloan Kettering Cancer Center@Phelps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported expenses associated with colon cancer treatment and living with this illness.
Time Frame: conclusion of study
conclusion of study

Secondary Outcome Measures

Outcome Measure
Time Frame
The perceived impact of cancer on patients' overall financial and social well-being.
Time Frame: conclusion of study
conclusion of study
The awareness of cancer support organizations and their utilization of informal and formal supports during treatment.
Time Frame: conclusion of study
conclusion of study
The patients' unmet resource and service needs during treatment.
Time Frame: conclusion of study
conclusion of study
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
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Albert Einstein College of Medicine
National Institutes of Health (NIH)
State University of New York - Downstate Medical Center
Ralph Lauren Center for Cancer Care and Prevention

Investigators

  • Principal Investigator: Elena Elkin, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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