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Trial registered on ANZCTR


Registration number
ACTRN12614000516684
Ethics application status
Approved
Date submitted
12/03/2014
Date registered
15/05/2014
Date last updated
3/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Patient Remote Intervention and Symptom Management System (PRISMS): a telehealth mediated nurse-led intervention to enable real time monitoring and better management of chemotherapy side-effects in haematological cancer patients.
Scientific title
A randomised controlled trial to assess the impact of a technology mediated nurse-led intervention on management of chemotherapy side effects in haematological cancer patients.
Secondary ID [1] 284175 0
NHMRC1004553
Universal Trial Number (UTN)
Trial acronym
PRISMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Monitoring symptoms in haematological cancer patients 291271 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma 291272 0
Leukaemia - Chronic leukaemia 291273 0
Hodgkin's 291274 0
Condition category
Condition code
Cancer 291625 291625 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 291626 291626 0 0
Leukaemia - Chronic leukaemia
Cancer 291627 291627 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 questionnaires take approximately two minutes to complete each.
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 enabled android tablet. The handset contains an application that prompts patients to complete a side-effect assessment questionnaire by following instructions on the touch screen tablet. Normal phone functions are disabled. All patients will be provided with the android tablet device and SIM card for the trial.
Intervention code [1] 288873 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] 291559 0
The first primary outcomes is nausea of at least 0.4 standard deviations as measured by the Rotterdam Symptom Checklist.
Timepoint [1] 291559 0
Mid-cycle 4 of chemotherapy treatment
Primary outcome [2] 292115 0
The second primary outcome is mucositis of at least 0.4 standard deviations as measured by the Rotterdam Symptom Checklist.
Timepoint [2] 292115 0
Mid-cycle 4 of chemotherapy treatment
Primary outcome [3] 292116 0
The third primary outcome is constipation of at least 0.4 standard deviations as measured by the Rotterdam Symptom Checklist.
Timepoint [3] 292116 0
Mid-cycle 4 of chemotherapy treatment
Secondary outcome [1] 307074 0
A secondary outcome of the PRISMS intervention will be nausea, mucositis, constipation and fatigue as measured by the Rotterdam Symptom Checklist (comparing the intervention group to the usual care group).
Timepoint [1] 307074 0
Mid-cycles 2 and 3 of chemotherapy
Secondary outcome [2] 307075 0
Another secondary outcome of the PRISMS intervention will be vomiting and diarrhea as measured by the Rotterdam Symptom Checklist (comparing the intervention group to the usual care group).
Timepoint [2] 307075 0
Mid-cycles 2, 3 and 4 of chemotherapy
Secondary outcome [3] 307076 0
Another secondary outcome of the PRISMS intervention will be: psychological distress as measured by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 307076 0
Mid-cycles 2, 3 and 4 of chemotherapy
Secondary outcome [4] 307077 0
Another secondary outcome of the PRISMS intervention will be: quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
Timepoint [4] 307077 0
Mid-cycles 2, 3 and 4 of chemotherapy
Secondary outcome [5] 308225 0
Another secondary outcome of the PRISMS intervention will be: patient activation as measured by the short form of the Patient Activation Measure (PAM)
Timepoint [5] 308225 0
At the end of cycle 4 of chemotherapy
Secondary outcome [6] 308226 0
Another secondary outcome of the PRISMS intervention will be: cancer treatment information and support needs as measured by the Cancer Treatament Survey (CaTS)
Timepoint [6] 308226 0
At the end of cycle 4 of chemotherapy
Secondary outcome [7] 308227 0
Cost effectiveness: a medical record audit for patient health system usage and cost & a patient health services and costs interview to capture health costs not reported in the primary record.
Timepoint [7] 308227 0
At the end of each of the first four cycles of chemotherapy .

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 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 treatment 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.
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 and chemotherapy protocol toxicity, and disease.
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
The primary outcomes for this longitudinal randomised controlled trial are nausea, mucositis, constipation and fatigue as assessed by the Rotterdam Symptom Checklist. All four items have a possible scale range of 3. These outcomes were chosen because they are common in patients receiving chemotherapy, are targeted by the PRISMS intervention and have demonstrated improvement following telehealth interventions.
Sample size calculations were based on 80% power, a two-sided independent-samples t-test with an alpha level of 0.05 and a standardised effect size of 0.4. In the absence of minimal important difference estimates for the Rotterdam Symptom Checklist, or any other symptom assessment tool validated for use in cancer patients, evidence-based effect sizes for the EORTC QLQ-C30 symptom scales and individual items were used as a guide (see note) In this case, for all QLQ-C30 scales/items excepting the Dyspnea item, a standardised effect of 0.4 represents the lower threshold of a medium-sized clinically relevant difference between groups of cancer patients. Given these specifications, a total of 200 patients (100 per arm) is required. Assuming attrition of up to 10%, a total of 222 patients (111 per arm) are needed at baseline.

Note:
Cocks, K., et al., Evidence-based guidelines for determination of sample size and interpretation of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Journal of Clinical Oncology, 2011. 29(1): p. 89-96.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
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)
QLD,VIC
Recruitment hospital [1] 2156 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 2158 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 7831 0
3002 - East Melbourne
Recruitment postcode(s) [2] 7832 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 288804 0
Government body
Name [1] 288804 0
NHMRC
Address [1] 288804 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 288804 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
St Andrews Place
East Melbourne, Victoria
3002
Country
Australia
Secondary sponsor category [1] 287500 0
None
Name [1] 287500 0
Address [1] 287500 0
Country [1] 287500 0
Other collaborator category [1] 277849 0
Hospital
Name [1] 277849 0
Icon Cancer Care
Mater Private Hospital
South Brisbane
Address [1] 277849 0
Mater Medical Centre
Level 5
293 Vulture Street
South Brisbane
QLD 4101
Country [1] 277849 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290650 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 290650 0
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
Ethics committee country [1] 290650 0
Australia
Date submitted for ethics approval [1] 290650 0
Approval date [1] 290650 0
04/12/2013
Ethics approval number [1] 290650 0
13/154

Summary
Brief summary
The study is evaluating if a mobile phone based system can support patients to monitor their side effects, promote the delivery of evidence based self-care advice in a timely manner, and mediate the role of nurses to effectively provide real-time patient support. Who is it for? You may be eligible to join this study if you are aged over 18 years and have a diagnosis of one of three haematological cancers (Hodgkin's Lymphoma, Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukaemia), and are receiving four or more cycles of chemotherapy treatment. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will be required to complete a symptoms questionnaire twice daily on a device (morning and afternoon) from Cycle 1 - Cycle 4 of their chemotherapy treatment. 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, and an amber alert occurs if a patient reports a symptom requiring non-urgent attention. In the case of an alert, the nurse will contact the patient by phone and query the symptom, provide self-care advice and support. The device is a mobile phone enabled Android tablet. The handset contains an application that prompts patients to complete a side-effect assessment questionnaire by following instructions on the touch screen tablet. Normal phone functions are disabled. All patients will be provided with the android tablet device and SIM card for the trial. Participants in the second study group will continue to receive usual care, which involves the regular appointments with their medical treatment team, provision of hospital contact details and education about chemotherapy prior to first cycle.
Trial website
Trial related presentations / publications
Breen, S., Ritchie, D., Schofield, P., Hsueh, Y.-s., Gough, K., Santamaria, N., Kamateros, R., Maguire, R., Kearney, N. & Aranda, S. 2015. The Patient Remote Intervention and Symptom Management System (PRISMS)–a Telehealth-mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial. Trials, 16, 1.
Aranda, S., Breen, S., Ritchie, D., Schofield, Gough, K., & Hargraves, M., 2013 “The Patient Remote Intervention & Symptom Management System (PRISMS)” (oral presentation), Behavioural Research in Cancer Control Conference, Adelaide, Australia.
Aranda, S., Breen, S., Ritchie, D., Schofield, Gough, K., & Hargraves, M., 2013 “The Patient Remote Intervention & Symptom Management System (PRISMS)” (poster presentation and live system demonstration), International Society for Remote Internet Interventions, Chicago, USA.
Aranda, S., Breen, S., Ritchie, D., Schofield, Gough, K., & Hargraves, M., 2013 “The Patient Remote Intervention & Symptom Management System (PRISMS)” (oral presentation), Informa National Cancer Centres Symposium, Melbourne.
Public notes

Contacts
Principal investigator
Name 46598 0
Prof Sanchia Aranda
Address 46598 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
Country 46598 0
Australia
Phone 46598 0
+61 2 8063 4111
Fax 46598 0
Email 46598 0
Sanchia.Aranda@cancer.org.au
Contact person for public queries
Name 46599 0
Dr Jo Phipps-Nelson
Address 46599 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
Country 46599 0
Australia
Phone 46599 0
+61 3 9656 1111
Fax 46599 0
Email 46599 0
Jo.Phipps-Nelson@petermac.org
Contact person for scientific queries
Name 46600 0
Dr Jo Phipps-Nelson
Address 46600 0
Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
Country 46600 0
Australia
Phone 46600 0
+61 3 9656 1111
Fax 46600 0
Email 46600 0
Jo.Phipps-Nelson@petermac.org

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