Condition category
Cancer
Date applied
21/03/2013
Date assigned
26/03/2013
Last edited
13/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Jon Moss

ORCID ID

Contact details

Professor Jon Moss
Interventional Radiology Unit
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
jon.moss@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAVA 2013

Study information

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

Acronym

CAVA

Study hypothesis

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

Ethics approval

Ethics approval has been sought from the West of Scotland REC 1. Reference Number: 13/WS/0056. Provisional approval for the CAVA trial was received on 11th March 2013.

Study design

Randomised controlled trial incorporating pre and post trial qualitative research

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Venous Access in Cancer Patients

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

Phase

Not Applicable

Drug names

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.

Overall trial start date

01/06/2013

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

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

Recruitment start date

01/06/2013

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor Jon Moss
Glasgow
G12 0YN
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

Dr Nathaniel Brittain
Academic Research Co-ordinator
NHS Greater Glasgow and Clyde
Research and Development Central Office
The Tennent Institute
1st Floor
Western Infirmary General
38 Church Street
Glasgow
G11 6NT
United Kingdom
Nathaniel.Brittain@ggc.scot.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment (HTA) programme (project reference 11/67/01).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes