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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.
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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.
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Secondary ID [1]
284175
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NHMRC1004553
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Universal Trial Number (UTN)
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Trial acronym
PRISMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Monitoring symptoms in haematological cancer patients
291271
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
291272
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Leukaemia - Chronic leukaemia
291273
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Hodgkin's
291274
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Condition category
Condition code
Cancer
291625
291625
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
291626
291626
0
0
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Leukaemia - Chronic leukaemia
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Cancer
291627
291627
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0
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
288873
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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The first primary outcomes is nausea of at least 0.4 standard deviations as measured by the Rotterdam Symptom Checklist.
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Assessment method [1]
291559
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Timepoint [1]
291559
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Mid-cycle 4 of chemotherapy treatment
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Primary outcome [2]
292115
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The second primary outcome is mucositis of at least 0.4 standard deviations as measured by the Rotterdam Symptom Checklist.
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Assessment method [2]
292115
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Timepoint [2]
292115
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Mid-cycle 4 of chemotherapy treatment
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Primary outcome [3]
292116
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The third primary outcome is constipation of at least 0.4 standard deviations as measured by the Rotterdam Symptom Checklist.
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Assessment method [3]
292116
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Timepoint [3]
292116
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Mid-cycle 4 of chemotherapy treatment
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Secondary outcome [1]
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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).
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Assessment method [1]
307074
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Timepoint [1]
307074
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Mid-cycles 2 and 3 of chemotherapy
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Secondary outcome [2]
307075
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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).
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Assessment method [2]
307075
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Timepoint [2]
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Mid-cycles 2, 3 and 4 of chemotherapy
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Secondary outcome [3]
307076
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Another secondary outcome of the PRISMS intervention will be: psychological distress as measured by the Hospital Anxiety and Depression Scale (HADS)
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Assessment method [3]
307076
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Timepoint [3]
307076
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Mid-cycles 2, 3 and 4 of chemotherapy
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Secondary outcome [4]
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Another secondary outcome of the PRISMS intervention will be: quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
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Assessment method [4]
307077
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Timepoint [4]
307077
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Mid-cycles 2, 3 and 4 of chemotherapy
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Secondary outcome [5]
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Another secondary outcome of the PRISMS intervention will be: patient activation as measured by the short form of the Patient Activation Measure (PAM)
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Assessment method [5]
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Timepoint [5]
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At the end of cycle 4 of chemotherapy
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Secondary outcome [6]
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Another secondary outcome of the PRISMS intervention will be: cancer treatment information and support needs as measured by the Cancer Treatament Survey (CaTS)
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Assessment method [6]
308226
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Timepoint [6]
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At the end of cycle 4 of chemotherapy
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Secondary outcome [7]
308227
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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.
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Assessment method [7]
308227
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Timepoint [7]
308227
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At the end of each of the first four cycles of chemotherapy .
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
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Actual
16/12/2013
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Date of last participant enrolment
Anticipated
31/12/2015
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Actual
29/09/2015
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Date of last data collection
Anticipated
31/12/2015
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Actual
2/12/2015
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Sample size
Target
222
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Accrual to date
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Final
87
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
2156
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Peter MacCallum Cancer Institute - East Melbourne
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Recruitment hospital [2]
2158
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Mater Private Hospital - South Brisbane
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Recruitment postcode(s) [1]
7831
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3002 - East Melbourne
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Recruitment postcode(s) [2]
7832
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
288804
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Government body
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Name [1]
288804
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NHMRC
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Address [1]
288804
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
288804
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Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
St Andrews Place
East Melbourne, Victoria
3002
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Country
Australia
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Secondary sponsor category [1]
287500
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None
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Name [1]
287500
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Address [1]
287500
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Country [1]
287500
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Other collaborator category [1]
277849
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Hospital
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Name [1]
277849
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Icon Cancer Care
Mater Private Hospital
South Brisbane
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Address [1]
277849
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Mater Medical Centre
Level 5
293 Vulture Street
South Brisbane
QLD 4101
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Country [1]
277849
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
290650
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Peter MacCallum Cancer Centre Ethics Committee
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Ethics committee address [1]
290650
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Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
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Ethics committee country [1]
290650
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Australia
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Date submitted for ethics approval [1]
290650
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Approval date [1]
290650
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04/12/2013
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Ethics approval number [1]
290650
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13/154
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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.
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Trial website
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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.
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Public notes
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Contacts
Principal investigator
Name
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Prof Sanchia Aranda
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Address
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Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
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Country
46598
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Australia
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Phone
46598
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+61 2 8063 4111
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Fax
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Email
46598
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[email protected]
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Contact person for public queries
Name
46599
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Dr Jo Phipps-Nelson
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Address
46599
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Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
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Country
46599
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Australia
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Phone
46599
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+61 3 9656 1111
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Fax
46599
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Email
46599
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[email protected]
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Contact person for scientific queries
Name
46600
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Dr Jo Phipps-Nelson
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Address
46600
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Peter MacCallum Cancer Centre
Locked Bag 1
A'Beckett Street
Melbourne
Victoria
8006
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Country
46600
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Australia
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Phone
46600
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+61 3 9656 1111
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Fax
46600
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Email
46600
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Exploring the use of Mobile applications by cancer patients undergoing chemotherapy: A scoping review.
2020
https://dx.doi.org/10.1016/j.ijmedinf.2020.104293
N.B. These documents automatically identified may not have been verified by the study sponsor.
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