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NCT01152879 Clinical Trial

Home Parenteral Nutrition in Cancer Patients

Cancer Clinical Trial

Official title:
An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01152879
Other study ID # SRMC 10-03
Secondary ID
Status Completed
Phase N/A
First received June 24, 2010
Last updated February 20, 2014
Start date May 2010
Est. completion date June 2013

Study information
Verified date February 2014
Source Southwestern Regional Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

This is a prospective descriptive non-randomized clinical study to examine quality of life outcomes and use of pain and anti-emetic therapy for patients receiving HPN support. The EORTC QLQ-C30 will be used to evaluate quality of life. All subjects will be monitored monthly throughout the course of treatment for a minimum of 3 months and a maximum of 1 year.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Home Parenteral Nutrition
Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage

Locations
Country Name City State
United States Cancer Treatment Centers of America at Southwestern Regional Medical Center Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Southwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Pain and nausea medication usage To examine the effect of home parenteral nutrition on the use of pain medication and anti-emetic therapy administered intravenously, subcutaneously, or orally. Monthly for a minumum of 3 months to a maximum of 12 months No
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