The Effects of Aggressive Patient Management on Cancer Therapy Management

This study has been withdrawn prior to enrollment.
(Investigator decided not to pursue)
Sponsor:
Information provided by (Responsible Party):
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00962572
First received: August 18, 2009
Last updated: April 6, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Cancer
Behavioral: Patient management

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Effects of Aggressive Patient Management on Cancer Therapy Management

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Patient management
    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.
Detailed Description:

This is an observational study of the effects of aggressive patient management. The records of 50 patients treated under the aggressive management plan will be matched with the records of 50 previous patients and attempts made to assess the improvement, if any, found. Statistical analysis will compare the outcomes of the study group and the matched control group for initial completion of planned therapy as per prescription, weight loss during therapy, intercurrent illness, and intercurrent hospitalizations. Long term analysis will compare the study group's outcomes (compared to expected outcomes) compared to the matched control group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

rural and minority patients who require radiation therapy

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962572

Locations
United States, Mississippi
University of Mississippi Radiation Oncology
Jackson, Mississippi, United States, 39213
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Michael C Baird, MD University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00962572     History of Changes
Other Study ID Numbers: 2008-0093
Study First Received: August 18, 2009
Last Updated: April 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Outcomes
Cancer
Radiotherapy
Socio-economic

ClinicalTrials.gov processed this record on April 15, 2014