CAVA - Cancer And Venous Access
| ISRCTN | ISRCTN44504648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44504648 |
| Secondary identifying numbers | CAVA 2013 |
- Submission date
- 21/03/2013
- Registration date
- 26/03/2013
- Last edited
- 22/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof Jon Moss
Scientific
Scientific
Professor Jon Moss
Interventional Radiology Unit
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
| jon.moss@ggc.scot.nhs.uk |
Study information
| Study design | Randomised controlled trial incorporating pre and post trial qualitative research |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study 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(s) | 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 11/03/2013. |
| 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 | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/06/2013 |
| Overall study end date | 30/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 1061 |
| 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 |
| Recruitment start date | 01/06/2013 |
| Recruitment end date | 28/02/2019 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Gartnavel General Hospital
Glasgow
G12 0YN
United Kingdom
G12 0YN
United Kingdom
Sponsor information
NHS Greater Glasgow and Clyde (UK)
Government
Government
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 | |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
NIHR Health Technology Assessment (HTA) programme (project reference 11/67/01).
No information available
Results and Publications
| Intention to publish date | 01/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | patient acceptability qualitative results | 09/07/2019 | 04/08/2020 | Yes | No |
| Results article | results | 20/07/2021 | 27/07/2021 | Yes | No |
| Results article | 01/07/2021 | 29/07/2021 | Yes | No | |
| Plain English results | CRUK plain English summary and results | 22/07/2022 | 22/07/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/07/2022: A plain English results link has been added.
29/07/2021: Publication reference added.
27/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
04/08/2020: Publication reference added.
04/12/2019: The following changes were made to the trial record:
1. The recruitment end date was updated from 28/02/2018 to 28/02/2019.
2. The overall trial end date was updated from 28/02/2019 to 30/09/2019.
3. The intention to publish date was updated from 30/09/2019 to 01/02/2020.
19/10/2018: The following changes were made to the trial record:
1. The recruitment end date was updated from 30/09/2018 to 28/02/2018.
2. The overall trial end date was updated from 30/09/2018 to 28/02/2019.
3. The intention to publish date was added.
