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Trial registered on ANZCTR


Registration number
ACTRN12611000186954
Ethics application status
Not yet submitted
Date submitted
14/02/2011
Date registered
16/02/2011
Date last updated
16/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a remote symptom monitoring in haematological cancer patients - a randomised controlled trial
Scientific title
Improving outcomes for haematological cancer patients receiving chemotherapy: a randomised controlled trial to assess the impact of a technology mediated nurse-led intervention
Secondary ID [1] 253602 0
NHMRC1004553
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Monitoring symptoms in haematological cancer patients 261162 0
Condition category
Condition code
Cancer 259316 259316 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 259340 259340 0 0
Leukaemia - Chronic leukaemia
Cancer 259341 259341 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telehealth system with nurse led support. Patients complete a symptoms questionnaire twice daily on a device(morning and afternoon) from Cycle 1 - Cycle 4 of chemotherapy.
The intervention nurse monitors symptoms and responds if any alerts are triggered. A red alert occurs if a patient reports a symptom requiring urgent attention, a amber alert occurs if a patient reports a symptom requring non-urgent attention.
In the case of an alert, the nurse will contact the patient by phone and query the symptom, provide self care and support.
The device is a mobile phone based system. The handset contains an application that prompts patients to complete a side-effect assessment questionnaire by following instructions on the touch screen handset. Normal phone functions are disabled. All patients will be provided with the mobile phone handset and SIM card for the trial.
Intervention code [1] 258024 0
Treatment: Devices
Comparator / control treatment
Usual care, which involves the regular appointments with medical treatment team, provision of hospital contact details and education about chemotherapy prior to first cycle.
Control group
Active

Outcomes
Primary outcome [1] 262120 0
Psychological distress: Hospital Anxiety and Depression Scale Total Score
Completed with Patient Self Report in a questionnaire booklet
Timepoint [1] 262120 0
At completion of 2 cycles of chemotherapy, three cycles and four cycles.
Secondary outcome [1] 273198 0
Quality of life with the Functional Assessment of Cancer Therapy General (FACT-G).
Completed with Patient Self Report in a questionnaire booklet
Timepoint [1] 273198 0
At completion of 2 cycles of chemotherapy, three cycles and four cycles.
Secondary outcome [2] 273199 0
Symptom burden: Rotterdam Symptom Checklist (RSCL)
Completed with Patient Self Report in a questionnaire booklet
Timepoint [2] 273199 0
At completion of 2 cycles of chemotherapy, three cycles and four cycles.
Secondary outcome [3] 273200 0
Cancer treatment related information: Cancer Treatment Scale (CaTS)
Completed with Patient Self Report in a questionnaire booklet
Timepoint [3] 273200 0
At completion of 2 cycles of chemotherapy, three cycles and four cycles.
Secondary outcome [4] 273201 0
Patient activation: Patient Activation Measure
Completed with Patient Self Report in a questionnaire booklet
Timepoint [4] 273201 0
At completion of 2 cycles of chemotherapy, three cycles and four cycles.
Secondary outcome [5] 273202 0
Health utility: EQ5D
Completed with Patient Self Report in a questionnaire booklet
Timepoint [5] 273202 0
At completion of four cycles of chemotherapy
Secondary outcome [6] 273203 0
Patient health services and costs questionnaire: Questionnaire currently being developed for this trial.
Completed with Patient Self Report in a questionnaire booklet
Timepoint [6] 273203 0
At completion of 2 cycles of chemotherapy, three cycles and four cycles.

Eligibility
Key inclusion criteria
Have a diagnosis of one of three haematological cancers (Hodgkin's lymphoma, Non-hodgkin's lymphoma or Chronic Lymphocytic Leukemia)
Be receiving four or more cycles of chemotherapy treatment in a day treatment unit
Be over 18 years of age
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Having a key cognitive psychological disorder as assessed by the treatmetn team
Unable to speak/read/write English
Participating in a clinical drug trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be approached and will be provided verbal and written information about the study, including a questionnaire booklet of outcome measures.
Participants will be enrolled once they provide signed consent and the baseline questionnaire.
The person who determined eligibility was unaware of patient allocation at the time of appraoch. The method to conceal allocation was by computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method to create the random order generation will be with an established computer software program which will be run for each patient after they have consented and been registered on the trial.
Stratification will occur by hospital site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3621 0
3002
Recruitment postcode(s) [2] 3622 0
3052

Funding & Sponsors
Funding source category [1] 258499 0
Government body
Name [1] 258499 0
NHMRC
Address [1] 258499 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 258499 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne, Victoria
8006
Country
Australia
Secondary sponsor category [1] 257635 0
Hospital
Name [1] 257635 0
Royal Melbourne Hospital
Address [1] 257635 0
Gratten Street
Parkville
Victoria
3052
Country [1] 257635 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260487 0
Ethics committee address [1] 260487 0
Ethics committee country [1] 260487 0
Date submitted for ethics approval [1] 260487 0
01/03/2011
Approval date [1] 260487 0
Ethics approval number [1] 260487 0

Summary
Brief summary
People with cancer are required to monitor and to initiate self care activities to manage side effects at home. In haematological cancer patients these side effects are often severe and life threatening. Safe home care requires close communication with the health team. We will test if a mobile phone based system can support patietns to monitor their side effects, promote the delviery of evidence based self care advice in a timely manner, and mediate the role of nurses to effectively provide real-time patient support.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32210 0
Address 32210 0
Country 32210 0
Phone 32210 0
Fax 32210 0
Email 32210 0
Contact person for public queries
Name 15457 0
Dr Sibilah Breen
Address 15457 0
Dept. Nursing & Supportive Care Research
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett St
Melbourne
Victoria 8006
Country 15457 0
Australia
Phone 15457 0
+61 3 9656 1667
Fax 15457 0
Email 15457 0
sibilah.breen@petermac.org
Contact person for scientific queries
Name 6385 0
Dr Sibilah Breen
Address 6385 0
Dept. Nursing & Supportive Care Research
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett St
Melbourne
Victoria 8006
Country 6385 0
Australia
Phone 6385 0
+61 3 9656 1667
Fax 6385 0
Email 6385 0
sibilah.breen@petermac.org

No information has been provided regarding IPD availability
Summary results
No Results