Satisfaction With Placement of Implantable Venous Access Devices in Patients With Solid Tumors

March 30, 2017 updated by: Kristin Ancell, Vanderbilt University

Patient Satisfaction With Placement of Implantable Venous Access Devices

RATIONALE: Gathering information about patients with solid tumors who have implantable venous access devices may help doctors learn more about patient satisfaction.

PURPOSE: This phase I trial is studying satisfaction with placement of implantable venous access devices in patients with solid tumors.

Study Overview

Status

Terminated

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment

Detailed Description

OBJECTIVES:

To determine patient satisfaction with subcutaneous venous-access device placement in oncology patients.

OUTLINE: Patients complete a computer-based survey while in the treatment area of the Vanderbilt Oncology Clinic. Basic demographic information and basic information regarding the placement of the device and complications are collected from the patient's medical record.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Tennessee
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37064
    - Vanderbilt-Ingram Cancer Center - Cool Springs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Diagnosis of a solid tumor malignancy
- No hematological malignancy
Patient at the Vanderbilt Oncology Clinic
Has undergone placement of a subcutaneous, single-lumen venous-access device within the past 6 months
- No patients who have had ≥ 2 venous-access devices placed by ≥ 1 department

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Not currently undergoing preparation for or process of stem cell transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Health Services Research
Allocation: N/A
Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall satisfaction with port placement Time Frame: n/a - study closed	n/a - study closed

Secondary Outcome Measures

Outcome Measure
Frequency of complications
Frequency of port failure
Need for removal of device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Kristin Ancell, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 2, 2010

First Submitted That Met QC Criteria