Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001563459
Ethics application status
Approved
Date submitted
23/01/2016
Date registered
11/11/2016
Date last updated
11/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a new process for chemotherapy prescription and preparation for adult cancer patients attending a day care hospital
Scientific title
Effect of a new process for chemotherapy prescription and preparation on quality of life in adult cancer patients attending a day care hospital.
Secondary ID [1] 288404 0
none
Universal Trial Number (UTN)
U1111-1178-7483
Trial acronym
CAPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer patients quality of life 297413 0
Condition category
Condition code
Cancer 297599 297599 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be segregated into 2 groups:
Group A: experimental group. In this group, patients will have their blood check the day before chemotherapy administration. Later in the day, patients will have either a phone call (for those living more than 35 km away) or a consultation with the oncologist at the clinic (for those living less than 35 km away). After that the oncologist will prescribe the chemotherapy that will be prepared by the pharmacist the day before administration. So in group A,blood test, consultation, prescription and chemotherapy preparation all occur on a single day, with chemotherapy administration occurring the following day.
Group B: control group. In this group, no modification will be brought to patient care. Meaning: blood check, consultation, prescription ,preparation and administration of the chemotherapy all the same day.
All patients attending the day care clinic and all their chemotherapy treatments will be included into the study. The change in our day care clinic organization is definitive. The allocated process will be continued until the end of chemotherapy. The duration of treatment will depend on the chemotherapy regimen choosen for each individual patient.
Intervention code [1] 294952 0
Diagnosis / Prognosis
Intervention code [2] 294953 0
Treatment: Other
Comparator / control treatment
Control group. In this group, no modification will be brought to patient care. Meaning: blood check, consultation, prescription ,preparation and administration of the chemotherapy all the same day.
Control group
Active

Outcomes
Primary outcome [1] 297144 0
Quality of life assessed by the EORTC QLQ-C30 questionnaire (proportion of participants with an improved quality of life)
Timepoint [1] 297144 0
At Baseline and 1 year post enrolment
Secondary outcome [1] 320155 0
Waiting time to receive chemotherapy for outpatient. It will be assessed using patient electronic medical records
Timepoint [1] 320155 0
At Baseline and 1 year post enrolment
Secondary outcome [2] 320156 0
The bed occupancy rate at the day care clinic. This will be assessed using hospital electronic records.
Timepoint [2] 320156 0
This will be study during a whole year (daily bed occupancy will be recorded) from the date of first participant enrolment.
Secondary outcome [3] 320157 0
Number of treatment deferrals on the scheduled day. This will be assessed using patient medical electronic records.
Timepoint [3] 320157 0
At Baseline and 1 year post enrolment
Secondary outcome [4] 320158 0
Evaluation of the nursing activities. For nurses: we wil use hospital electronic records for the number of chemotherapy cures administrered per time unit (20 minutes).
Timepoint [4] 320158 0
This will be assessed during a continuous period of 1 year (whole year from the date of first participant enrolment) .
Secondary outcome [5] 328985 0
Evaluation of the pharmacist activities. For the pharmacists: we will use hospital electronic records for the number of chemotherapy cures prepared per time unit (20 minutes).
Timepoint [5] 328985 0
This will be assessed during a continuous period of 1 year (whole year from the date of first participant enrolment)

Eligibility
Key inclusion criteria
18 years old
Cancer patient receiving chemotherapy as an outpatient
Given informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients included in clinical trials
No given informed consent
No will to participate

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We need 300 patients: 200 in the group A and 100 in the group B. This number was determined by an exploratory study where we used a bilateral test. With this number, we will have a power of 0.8 and an alpha value of 0.05
Effect size 0.36

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2017
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 7547 0
Belgium
State/province [1] 7547 0

Funding & Sponsors
Funding source category [1] 292753 0
Hospital
Name [1] 292753 0
CHU UCL Namur site Godinne
Country [1] 292753 0
Belgium
Primary sponsor type
Hospital
Name
CHU UCL Namur site Godinne
Address
Rue G Therasse 1
5530 Yvoir
Country
Belgium
Secondary sponsor category [1] 291481 0
None
Name [1] 291481 0
Address [1] 291481 0
Country [1] 291481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294239 0
CHU UCL Namur site Godinne
Ethics committee address [1] 294239 0
Ethics committee country [1] 294239 0
Belgium
Date submitted for ethics approval [1] 294239 0
15/12/2015
Approval date [1] 294239 0
19/01/2016
Ethics approval number [1] 294239 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63010 0
Prof D'Hondt Lionel
Address 63010 0
Rue G Therasse 1
5530 Yvoir
Country 63010 0
Belgium
Phone 63010 0
+32 81 42 38 58
Fax 63010 0
+32 81 42 38 32
Email 63010 0
[email protected]
Contact person for public queries
Name 63011 0
D'Hondt Lionel
Address 63011 0
Rue G Therasse 1
5530 Yvoir
Country 63011 0
Belgium
Phone 63011 0
+32 81 42 38 58
Fax 63011 0
+32 81 42 38 32
Email 63011 0
[email protected]
Contact person for scientific queries
Name 63012 0
D'Hondt Lionel
Address 63012 0
Rue G Therasse 1
5530 Yvoir
Country 63012 0
Belgium
Phone 63012 0
+32 81 42 38 58
Fax 63012 0
+32 81 42 38 32
Email 63012 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.