Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03550690 |
| Other study ID # |
Rocket Project 1 |
| Secondary ID |
242415 |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2018 |
| Est. completion date |
July 2019 |
Study information
| Verified date |
June 2018 |
| Source |
Gloucestershire Hospitals NHS Foundation Trust |
| Contact |
Paul Perkins, MB BCh |
| Phone |
+441242230199 |
| Email |
paul.perkins[@]suerydercare.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Ascites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to
distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics
and ascitic drainage. Ascitic drainage is performed by inserting a plastic tube into the
abdomen and draining off the fluid under local anaesthetic, removing the drain afterwards.
For some, the fluid will return and the procedure needs repeating. A relatively new treatment
involves inserting a semi-permanent drain - a small plastic tube under the skin which is left
in place so that the fluid can be drained if it builds up again. The potential benefit to
patients is that afterwards they can have fluid removed at home. This might reduce the number
of hospital admissions, outpatient visits and the number of procedures they need to have in
the last few months of life. In Gloucestershire, the Rocket Indwelling Pleural Catheter (IPC)
is the semi-permanent drain of choice.
Our research group has a particular interest in the management of ascites and we recently
completed the first qualitative interview study with patients with this condition - patients
with ascites secondary to cancer. Patients were pleased to have semi-permanent drains in
place as it meant that repeated admissions to hospital were avoided. They did not have to
wait for a build-up of fluid before more could be drained off; and symptoms never had to
build up as badly as when they were having repeated ascitic drainage.
We plan a feasibility study to ascertain whether a definitive non-randomised study to detect
differences in quality of life between Rocket IPC and repeat ascitic drainage is possible and
how many patients would be needed for such a study.
Description:
Study Objective This feasibility study aims to establish how best to conduct a definitive
prospective non-randomised QOL study for patients with malignant ascites who either have
placement of a Rocket IPC or repeated LVP
Study Design This is an open label, non-randomised observational study. Each patient will
receive verbal and written information followed by signing of an Informed Consent Form prior
to participation. They will be asked to capture data about their QOL by completing paper
diaries.
If the patient has a relative / next of kin we will ask permission from the patient to
approach them to see if they would be happy to consent to helping with data collection for
the study.
Study Procedures
When patients are booked for ascitic drainage in hospitals or hospice a member of the
patient's clinical team will discuss the study with the patient (either in person or via
telephone). If in agreement, the doctor / nurse will pass on their contact details to a
member of the research team who will then telephone the patient and:
- Ask the patient if they would be happy to receive a patient information leaflet by post
or email
- Ask the patient if they would be happy for their relative / next of kin to be contacted
about this study. The relative / next of kin will then be contacted and, if they are
happy to receive it, a participant information leaflet will be posted or emailed to
them.
[If the patient is having an IPC fitted the relative may fit the inclusion criteria for the
related study, Rocket Project 2, so that this study may be discussed at this point and a
participant information leaflet provided too.]
At the time of admission for the procedure informed consent will be obtained from the patient
and the following information will be obtained and recorded on a case report form:
- Patient's age, gender, diagnosis
- Performance status
- How many LVPs the patient has had up until the current procedure
- Patient's understanding of treatment options for ascites management, in particular
whether Rocket IPC has been mentioned
- Why was this option chosen?
- Opinion about participation in a randomised trial if one was being conducted The
research nurse will ensure that baseline blood tests to include renal function and
albumin have been performed prior to the procedure.
Rarely, a patient could be referred for the procedure and have it performed later that day.
In that scenario we would like to have permission for a cooling off period to be waived by
the participants - we would argue that this is not a particularly burdensome study.
Informed consent will also be sought from the relative / next of kin. It will usually be
possible to do obtain this when the patient attends for the procedure but a separate
appointment to obtain informed consent may be needed at the relative / next of kin's home or
care setting.
A patient can be recruited to the study if their relative / next of kin does not consent OR
they have no relative / next of kin.
A four week diary will be given to the patient to capture the following information:
1. Number of LVPs / Rocket IPC drainage episodes performed*
2. Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC
drainage*
3. Any complications - catheter blockage, infections, hospital admissions*
4. The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY
5. The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY
6. The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL
Questionnaire (QLQ-C30) WEEKLY
7. Anti-cancer treatment received by the patient*
8. Diuretics received by the patient*
If a relative / next of kin has consented they can help the patient to complete their diary.
They will not be able to give a proxy measure for any of the quality of life scores but will
be able to assist the patient with completion of these and also with objective measures (e.g.
those marked * above) The research nurse will contact the patient frequently by phone, to
provide support with data collection, if required.
When the patient is close to completing 4 weeks in the study they will be offered the
opportunity to complete another 4 week diary. It will be explained to them that this is not
essential but will provide useful information.
When close to completing the 2nd 4 week diary (i.e. after 8 weeks) they will, once again, be
offered a further diary. Patients will complete a maximum of three diaries.
Patients will not be expected to complete questionnaires if they do not feel well enough or
lose capacity. Patients' clinical course can fluctuate and there may be a time when they feel
well enough to complete questionnaires again. Data about fluid volumes removed may still be
collected after a patient loses capacity by healthcare staff, as is routine practice, or
consenting relatives / next of kin.
Only patients with capacity will be approached for participation in the study.
Blood Tests Renal function and albumin will be measured at baseline, 6 weeks and 12 weeks
(the latter 2 time points only if the patient remains in the study after 4 weeks and 8 weeks)
- if necessary performed by the research nurse at patient's home.
Blood tests will not be performed on patients who have lost capacity for the purposes of this
study. If patients without capacity have blood tests taken for other reasons the results will
be used as part of data analysis.
Only a very small percentage of people living in Gloucestershire are not English speaking. It
has been decided that it is not cost effective to fund translation for this feasibility
study. The information on the numbers of patients / carers who may have been excluded and the
languages that might have been needed will be collected and this will be taken into account
when planning a larger study.
Outcome measures
There have been recommendations about suitable QOL measures for use with patients with
ascites. We discussed these with service users and carers and have agreed on using for this
study:
1. The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM)
2. The EuroQol questionnaire (EQ-5D) as a generic QOL measure
3. The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL
Questionnaire (QLQ-C30)
In addition we will ask healthcare professionals, patients or consenting carers (depending on
who manages the drain) to record volumes of fluid removed at each paracentesis and episode of
semi-permanent drainage.
We will ask patients and carers about:
Drainage complications and hospital admissions. Chemotherapy use Diuretic use
Withdrawal of subjects from the study
Patients will cease participation in the study when one of the following criteria is met:
They choose to withdraw They choose not to complete a further QOL diary They complete their
third monthly QOL diary They lose capacity and it is thought that this will be permanent
Carers will cease participation in the study when one of the following criteria is met:
They choose to withdraw The patient dies
A patient may remain in the study although a carer / next of kin has withdrawn and vice
versa.
Statistical Analysis Percentage presence and percentage completeness of the three QOL
measures will be evaluated. These results will allow an estimation of the number of patients,
resources and time needed to perform a definitive prospective non-randomised QOL study for
patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP.
The following analysis will also be conducted:
- QLQ-C30 and EQ-5D averaged for each participant for the duration of their participation,
using the area under the curve method.
- ESAS:AM analysed by estimating the prevalence of individual symptoms at each time point,
as well as the time-weighted average burden of symptoms for each participant.
It is hoped that data from the feasibility study can be used in the definitive study if the
methodology of the two studies remains the same.
We estimate over a 6-month period approximately 60 patients with ascites secondary to cancer
will have a paracentesis. We plan to recruit 20 patients having a drainage procedure (LVP or
Rocket IPC) within 6 months.
