CAVA - Cancer And Venous Access | Recruiting
CAVA - Cancer And Venous Access | Recruiting
CAVA - Cancer And Venous Access
CAVA

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Medical Conditions
  • Venous Access in Cancer Patients
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN44504648
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-central-lines-for-long-term-chemotherapy-cava
Research Details
  • To determine which venous access device - subcutaneously tunnelled central catheters (Hickman type device), peripherally inserted central catheters (PICC) or implantable chest wall ports (Port) - offers the best outcome from safety, clinical effectiveness and cost effectiveness perspectives.

    More details can be found at http://www.hta.ac.uk/2985
Phase
Not Applicable
Study Design
Randomised controlled trial incorporating pre and post trial qualitative research
Study Type
Interventional
Intervention

All patients will receive either a Port, PICC or Hickman Type device. There are four possible randomisation options for each patient. The site or patient will chose which randomisation option to be part of and then the patient will be randomised between the possible devices in that option. The options are:
• Hickman type device versus PICC
• Hickman type device versus chest wall port
• PICC versus chest wall port
• Hickman type device versus PICC versus chest wall port

Intervention Type
Other
Primary Outcome Measures
    The primary outcome for the randomised trial is complication rate, a composite of infection (suspected or confirmed) and/or mechanical failure. This will be analysed using logistic regression including terms for treatment group and randomisation stratification factors.
Secondary Outcome Measures
    An analysis will also be conducted based on complication event rate data 13. This analysis will estimate the effect of the access devices on the individual component complications (infections and mechanical failure) and will allow an assessment of the similarity of these effects via a likelihood ratio test. The incidence of venous thrombosis will be compared using logistic regression and also as an event rate. The frequency of the various complications will be assessed. The total duration of treatment interruptions will be summarised and compared using a Mann Whitney U-test.

    Scores for the five dimensions of the EQ-5D (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the visual analogue score for health will be summarised and the EQ-5D curves will be compared between treatment groups using an area under curve (AUC) approach standardised for the period on study and using the baseline value as a covariate.

    Scores for the 5 functional scales (physical, role, emotional, cognitive, social) and 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties) of the EORTC QLQ-C30 will be calculated according to standard EORTC conventions, as will global health status score. These scores will be summarised and analysed as EQ-5D.

    The results from the device-specific questionnaire will be summarised only.
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
2000
Participant Inclusion Criteria
    1. Aged ≥ 18 years
    2. Receiving or to receive chemotherapy
    3.Duration of chemotherapy ≥ 12 weeks
    4. Clinical team uncertain as to which device is optimal for this indication
    5. Solid or haematological malignancy
    6. Suitable upper extremity vein for all the access devices to which the patient may be randomised
    7. Able to provide written informed consent
Participant Exclusion Criteria
    1. Life or treatment expectancy <3 months
    2.Previous venous access device removed due to complication within last three months
    3. Requirement for high volume (apheresis) line
    4. Need for catheter to be placed in a non upper extremity vein
    5. Patient previously randomised into the CAVA tria
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Glasgow
G12 0YN
Trial Contact(s)
Primary Trial Contact
Prof Jon Moss
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Cancer And Venous Access (CAVA) – A randomised controlled trial with associated qualitative research of venous access devices for the delivery of long-term chemotherapy
EudraCT Number
Sorry, this information is not available
Funder(s)
  • NIHR Health Technology Assessment (HTA) programme (project reference 11/67/01).
Other Study ID Numbers
CAVA 2013
Sponsor(s)
NHS Greater Glasgow and Clyde (UK)
Key Dates

Recruitment Start Date

01 Jun 2013

Recruitment End Date

30 Sep 2018

Trial Start Date

01 Jun 2013

Trial End Date

30 Sep 2018

Date added to source

26 Mar 2013

Date updated in source

13 May 2014