NCT00774839

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

7.8 years

First QC Date

October 16, 2008

Last Update Submit

August 9, 2016

Conditions

Keywords

Newly DiagnosedColonStage IIStage III

Outcome Measures

Primary Outcomes (1)

  • Self-reported expenses associated with colon cancer treatment and living with this illness.

    conclusion of study

Secondary Outcomes (4)

  • The perceived impact of cancer on patients' overall financial and social well-being.

    conclusion of study

  • The awareness of cancer support organizations and their utilization of informal and formal supports during treatment.

    conclusion of study

  • The patients' unmet resource and service needs during treatment.

    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.

    conclusion of the study

Study Arms (1)

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

Interventions

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.

Also known as: 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.
Newly diagnosed stage II-III colon cancer 65 years or older

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memoral Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Location

Memorial Sloan Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, 11570, United States

Location

Memoral Sloan Kettering Cancer Center@Phelps

Sleepy Hollow, New York, United States

Location

Related Links

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

DemographyHealth

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Elena Elkin, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations