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Trial registered on ANZCTR


Registration number
ACTRN12612000635864
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
14/06/2012
Date last updated
1/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II of a novel telehealth-mediated nurse-led intervention to increase oral cancer therapy adherence amongst people with Chronic Myeloid Leukaemia (CML)
(REMIND study)
Scientific title
Phase II of a novel telehealth-mediated nurse-led intervention to increase oral cancer therapy adherence amongst people with Chronic Myeloid Leukaemia (CML)
(REMIND study)
Secondary ID [1] 280467 0
ALLG SC04
Universal Trial Number (UTN)
Trial acronym
REMIND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic myeloid leukaemia (CML) 286443 0
Condition category
Condition code
Cancer 286703 286703 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention lasts for 10 weeks. Patients receive daily SMS reminders to take medication. The patient will be asked to send a message once the dose is taken. Patients complete weekly symptom assessments on a web service that automatically generates self care advice. Weekly summaries of patients' symptoms and adherence rates are provided to the intervention nurse and treating clinician. In weeks 1,2,6 and 10, the intervention nurse calls patient and does the following:
a) establish the patient’s understanding of the diagnosis, current symptom experience and medication regimen; and current self-care strategies. The intervention nurse will then explore with the patient any barriers to treatment adherence; particularly side-effects or other negative consequences; provide evidence-based self-care strategies; explore with the patient the perceived benefits associated with medication adherence.
b) identify the top 3 concerns about medication adherence for each patient and address these concerns using evidence based self-care or coping strategies (such as, cognitive restructuring) to address or minimise the impact of concerns.
c) use recommended communication techniques (empathy, positive reinforcement, repetition, checking understanding) to discuss the regimen with the patient. At this point, the regimen may be tailored to suit the individual’s regular patterns of behaviour. Instructions for missed tablets will also be provided.
Intervention code [1] 284845 0
Behaviour
Comparator / control treatment
no intervention
Control group
Active

Outcomes
Primary outcome [1] 287097 0
Assess the clinical feasibility and acceptability of the intervention with 40 patients with CML by interviewing stakeholders involved e.g clinician, patient
Timepoint [1] 287097 0
end of trial
Primary outcome [2] 287111 0
To evaluate a nurse-led, telehealth-mediated intervention employing web and mobile based reminder systems (Remind) to help people with CML improve adherence to their oral medication and effectively manage medication side-effects better. Management of side effects will be evaluated through patient reproted outcomes on the The Memorial Symptom Assessment Scale Short Form. Adherence will be measured through pill counts.
Timepoint [2] 287111 0
end of trial
Secondary outcome [1] 297362 0
Determine the suitability of a specially designed pill monitoring device, supplied by Novartis, for future trials. This will be informally evaluated through discussion with select patients and clinicians.
Timepoint [1] 297362 0
end of trial
Secondary outcome [2] 297363 0
Determine the suitability of patient reported outcome measures and acceptability of new NIH-Funded Patient Reported Outcomes Measurement Interactive System28 (PROMIS) online data collection system for future trials. This will be informally evaluated through discussion with select patients and clinicians.
Timepoint [2] 297363 0
end of trial
Secondary outcome [3] 297364 0
Establish recruitment rates and research procedures to inform final design and methods of a future phase III trial
Timepoint [3] 297364 0
end of trial
Secondary outcome [4] 297365 0
Estimate the potential effect size and coefficient of variation on which to base power calculations for an adequately powered phase III trial
Timepoint [4] 297365 0
end of trial

Eligibility
Key inclusion criteria
1. a confirmed diagnosis of CML in the chronic phase with no signs and symptoms of progression to the accelerated or blastic phases as per investigator’s opinion
2. no evidence of Imatinib resistance (as determined by the site investigator)
3. Currently taking or about to commence treatment with Imatinib
4. over 18 years
5. proficient in English
6. able to give informed consent.
7. An ECOG performance status score of 2 or less at Screening
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Demonstrated cognitive or psychological difficulties that would preclude study participation as defined by the treatment team’s cognitive and / or psychiatric assessment or patient’s disclosed medical history
2. Too unwell to participate in the study as determined by the patient’s treatment team.

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



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NSW,QLD,SA,VIC
Recruitment hospital [1] 8670 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 8671 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 8672 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 8673 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 16782 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 16783 0
3000 - Melbourne
Recruitment postcode(s) [3] 16784 0
5000 - Adelaide
Recruitment postcode(s) [4] 16785 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 285236 0
Other Collaborative groups
Name [1] 285236 0
Australasian Leukaemia and Lymphoma Group
Address [1] 285236 0
Level 6, 372 Albert St.
East Melbourne, Vic., 3002.
Country [1] 285236 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Level 6, 372 Albert St.
East Melbourne, Vic., 3002.
Country
Australia
Secondary sponsor category [1] 284236 0
None
Name [1] 284236 0
Address [1] 284236 0
Country [1] 284236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287234 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 287234 0
305 Grattan Street, Melbourne VIC 3000.
Ethics committee country [1] 287234 0
Australia
Date submitted for ethics approval [1] 287234 0
01/07/2012
Approval date [1] 287234 0
03/06/2013
Ethics approval number [1] 287234 0

Summary
Brief summary
This study aims to evaluate a tele-health mediated nurse led intervention to increase oral cancer therapy adherence amongst people with Chronic Myeloid Leukaemia (CML). Who is it for? You may be eligible to join this study if you are aged 18 years or more and have a confirmed diagnosis of chronic myeloid leukaemia (CML). You should be currently taking or about to commence treatment with the drug, Imatinib. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive a nurse-led intervention using internet and mobile telephone reminder systems to help them remember to take their medicine and cope with medicine side effects. Participants in the other group will not receive this intervention. Information obtained from this trial will help to see if the intervention is suitable, whether the measures we are using to see if medicine uptake improves are working, and help us to work out the time required to accrue numbers of patients to a subsequent larger study using the same, or improved version of the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34159 0
Prof Penny Schofiled
Address 34159 0
Department of Nursing and Supportive Care Research Peter MacCallum Cancer Centre (Peter Mac) Locked Bag 1 A’Beckett Street VIC 8006
Country 34159 0
Australia
Phone 34159 0
+61 3 8559 5000
Fax 34159 0
Email 34159 0
Penelope.Schofield@petermac.org
Contact person for public queries
Name 17406 0
Prof Penelope Schofield
Address 17406 0
Department of Nursing and Supportive Care Research
Peter MacCallum Cancer Centre (Peter Mac)
Locked Bag 1
A’Beckett Street VIC 8006
Country 17406 0
Australia
Phone 17406 0
+61 3 8559 5000
Fax 17406 0
Email 17406 0
Penelope.Schofield@petermac.org
Contact person for scientific queries
Name 8334 0
Prof Penelope Schofield
Address 8334 0
Department of Nursing and Supportive Care Research
Peter MacCallum Cancer Centre (Peter Mac)
Locked Bag 1
A’Beckett Street VIC 8006
Country 8334 0
Australia
Phone 8334 0
+61 3 8559 5000
Fax 8334 0
Email 8334 0
Penelope.Schofield@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary