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This study has been withdrawn prior to enrollment.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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 18, 2009 | ||||
| Last Updated Date | April 6, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00962572 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Aggressive Patient Management on Cancer Therapy Management | ||||
| Official Title ICMJE | The Effects of Aggressive Patient Management on Cancer Therapy Management | ||||
| Brief Summary | A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective. |
||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | rural and minority patients who require radiation therapy |
||||
| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | 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. |
||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00962572 | ||||
| Other Study ID Numbers ICMJE | 2008-0093 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Mississippi Medical Center | ||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Mississippi Medical Center | ||||
| Verification Date | April 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||