NCT00962572

Brief Summary

A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 9, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

August 18, 2009

Last Update Submit

April 6, 2012

Conditions

Keywords

OutcomesCancerRadiotherapySocio-economic

Outcome Measures

Primary Outcomes (1)

  • To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol.

    1 year

Secondary Outcomes (1)

  • To test if increased compliance results in better therapy outcomes and fewer complications of the disease process as evidenced by increased survival and fewer intercurrent hospitalizations.

    1 year

Interventions

Aggressive patient management will be implemented by a corps of "patient manager" volunteers backed by a transportation, nutrition, and social services network. The social services professionals will work with the volunteers to establish the support needed for each patient. The volunteer managers will in turn constantly monitor that such support is addressing the patient's ability to be treated. Access to sponsored housing will be coordinated. Nutritional support will be coordinated by the Dietary department and will consist of counseling, and supplements when necessary. Provision of supplemental feeding for housed patients will be arranged.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

rural and minority patients who require radiation therapy

You may qualify if:

  • live 45 minutes from treatment facility
  • family income less than 200% federal poverty guideline

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Radiation Oncology

Jackson, Mississippi, 39213, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Care Management

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

  • Michael C Baird, MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 20, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

April 9, 2012

Record last verified: 2012-04

Locations