Home Parenteral Nutrition in Cancer Patients
An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral
1 other identifier
observational
100
1 country
1
Brief Summary
This study is being done to examine the effect of Parenteral (intravenous) nutrition support in the home setting on quality of life in cancer patients. In addition, this study is being done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2010
Typical duration for all trials
1 active site
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
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 21, 2014
February 1, 2014
3 years
June 24, 2010
February 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
To examine the effect of parenteral nutrition support in the home care setting on quality of life as measured by the EORTC QLQ-C30
Monthly for a minimum of 3 months to a maximum of 12 months
Secondary Outcomes (1)
Pain and nausea medication usage
Monthly for a minumum of 3 months to a maximum of 12 months
Study Arms (1)
Home Parenteral Nutrition
Patients receiving home parenteral nutrition
Interventions
Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage
Eligibility Criteria
Patient who are candidates for HPN will be identified by the Nutrition and Metabolic Support Team. Patients will be appropriate for HPN as indicated by a safe home environment, readiness for discharge, and reimbursement for the therapy at home. Candidates for HPN include: Patients will a nonfunctioning gastrointestinal tract. Patients that are moderately or severely malnourished (SGA B or C) with aniticipated deterioration in nutritional status due to aggressive treatment. Patients who have failured enteral feedings for nutrition support. Patients with life expectancy of greater than 3 months.
You may qualify if:
- Patients with a cancer diagnosis who have been receiving parenteral nutrition in the hospital or have started on HPN while at Cancer Treatment Centers of America and meet the criteria for home parenteral nutrition.
- Patient expected to have a life expectancy of greater than 90 days post discharge.
You may not qualify if:
- Patients less than 18 years of age
- HPN patients who do not receive nutrition assessment and follow-up by the Coram Healthcare nutrition support team
- Refuse to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross Taylor, MD
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 29, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
February 21, 2014
Record last verified: 2014-02