NCT01152879

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

3 years

First QC Date

June 24, 2010

Last Update Submit

February 20, 2014

Conditions

Keywords

Parenteral NutritionQuality of Life

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

Dietary Supplement: Home Parenteral Nutrition

Interventions

Home Parenteral NutritionDIETARY_SUPPLEMENT

Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage

Also known as: Intravenous nutrition
Home Parenteral Nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

Related Links

MeSH Terms

Conditions

NeoplasmsHyperphagia

Interventions

Parenteral Nutrition, Home

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Parenteral NutritionFeeding MethodsTherapeuticsNutritional SupportNutrition TherapyHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ross Taylor, MD

    Cancer Treatment Centers of America at Southwestern Regional Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations