Unspecified Adult Solid Tumor, Protocol SpecificNCT01098643
Satisfaction With Placement of Implantable Venous Access Devices in Patients With Solid Tumors
A study testing computer-assisted intervention, medical chart review and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Vanderbilt University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- computer-assisted intervention, medical chart review and questionnaire administration
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: 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.
Read the 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.
- Being tested
- computer-assisted intervention, medical chart review, questionnaire administration, survey administration
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer-assisted interventionOther
medical chart reviewOther
questionnaire administrationOther
survey administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction with port placement
Measured: n/a - study closed
Secondary outcomes (3)
Frequency of complications
Frequency of port failure
Need for removal of device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: not enough pts for available to reach goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kristin Ancell, Vanderbilt University
- Investigators
- Kristin Ancell, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098643
- Sponsor's protocol ID
- CDR0000669012
- Other IDs
- P30CA068485, VU-VICC-SUPP-0982
- Status last verified
- Mar 2010
- First submitted
- 2 Apr 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: never published, terminated
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Placement of Implantable Venous Access Devices
- ClinicalTrials.gov ID
- NCT01098643
- Acronym / sponsor ID
- CDR0000669012
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough pts for available to reach goal
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2009 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computer-assisted intervention | Other | – |
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| survey administration | Other | – |
Primary outcome
Overall satisfaction with port placement
Time frame: n/a - study closed
3 secondary outcomes
Frequency of complications
Frequency of port failure
Need for removal of device
Results and safety
The study was stopped early (reason given: not enough pts for available to reach goal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No. never published, terminated
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Ancell, MD principal investigator
Vanderbilt-Ingram Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer-assisted intervention, medical chart review and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough pts for available to reach goal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall satisfaction with port placement (time frame: n/a - study closed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.