CancerNCT00962572
The Effects of Aggressive Patient Management on Cancer Therapy Management
An observational study of Cancer, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Patient management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: rural and minority patients who require radiation therapy
Who may be able to join
- live 45 minutes from treatment facility
- family income less than 200% federal poverty guideline
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Radiation Oncology
Jackson, Mississippi, 39213
About this study
A study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective.
Read the 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.
- Conditions
- Cancer
- Being tested
- Patient management
- Keywords
- Outcomes, Cancer, Radiotherapy, Socio-economic
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient managementBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Investigator decided not to pursue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael C Baird, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962572
- Sponsor's protocol ID
- 2008-0093
- Status last verified
- Apr 2012
- First submitted
- 18 Aug 2009
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aggressive Patient Management on Cancer Therapy Management
- ClinicalTrials.gov ID
- NCT00962572
- Acronym / sponsor ID
- 2008-0093
- Conditions
- Cancer
- Keywords
- Outcomes, Cancer, Radiotherapy, Socio-economic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Investigator decided not to pursue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- rural and minority patients who require radiation therapy
Key inclusion criteria (2 listed)
- live 45 minutes from treatment facility
- family income less than 200% federal poverty guideline
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient managementAggressive 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. | Behavioural | – |
Primary outcome
To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol.
Time frame: 1 year
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Baird, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test effects of intensive patient management on patient's compliance with referral and subsequent treatment protocol. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.