Home Parenteral Nutrition in Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01152879
First received: June 24, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Cancer
Dietary Supplement: Home Parenteral Nutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral

Resource links provided by NLM:


Further study details as provided by Southwestern Regional Medical Center:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Monthly for a minimum of 3 months to a maximum of 12 months ] [ Designated as safety issue: No ]
    To examine the effect of parenteral nutrition support in the home care setting on quality of life as measured by the EORTC QLQ-C30


Secondary Outcome Measures:
  • Pain and nausea medication usage [ Time Frame: Monthly for a minumum of 3 months to a maximum of 12 months ] [ Designated as safety issue: No ]
    To examine the effect of home parenteral nutrition on the use of pain medication and anti-emetic therapy administered intravenously, subcutaneously, or orally.


Estimated Enrollment: 100
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Home Parenteral Nutrition
Patients receiving home parenteral nutrition
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
Other Name: Intravenous nutrition

Detailed 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.

  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

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152879

Locations
United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133
Sponsors and Collaborators
Southwestern Regional Medical Center
Investigators
Principal Investigator: Ross Taylor, MD Cancer Treatment Centers of America at Southwestern Regional Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT01152879     History of Changes
Other Study ID Numbers: SRMC 10-03
Study First Received: June 24, 2010
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Southwestern Regional Medical Center:
Parenteral Nutrition
Quality of Life

ClinicalTrials.gov processed this record on July 24, 2014