The Effects of Aggressive Patient Management on Cancer Therapy Management
This study has been withdrawn prior to enrollment.
(Investigator decided not to pursue)
Sponsor:
University of Mississippi Medical Center
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
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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:
Detailed Description:
-
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.
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 May 16, 2013