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

NCT01098643 | Terminated

• 3 other identifiers: CDR0000669012P30CA068485VU-VICC-SUPP-0982
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Overall satisfaction with port placement

  n/a - study closed

Secondary Outcomes (3)

• Frequency of complications

• Frequency of port failure

• Need for removal of device

Interventions

computer-assisted intervention OTHER

medical chart review OTHER

questionnaire administration OTHER

survey administration OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Study Officials

• Kristin Ancell, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 5, 2010
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 4, 2017

Record last verified: 2010-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)