Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001798257p
Ethics application status
Submitted, not yet approved
Date submitted
9/10/2018
Date registered
5/11/2018
Date last updated
21/10/2019
Date data sharing statement initially provided
5/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
SAMSON: Trial of a nurse and pharmacist-led mobile health management system.
Scientific title
SAMSON: Safety and adherence to medications and self-care advice in oncology. A randomised controlled feasibility and acceptability trial of a pharmacist and nurse-supported m-health platform.
Secondary ID [1] 296485 0
Nil known
Universal Trial Number (UTN)
U1111-1222-0334
Trial acronym
SAMSON
Linked study record
REMIND: Phase II of a novel telehealth-mediated nurse-led intervention to increase oral cancer therapy adherence amongst people with Chronic Myeloid Leukaemia (CML). ACTRN12612000635864
This record was the parent study.

Health condition
Health condition(s) or problem(s) studied:
chronic lymphocytic leukaemia 309970 0
small lymphocytic lymphoma 309971 0
mantle cell lymphoma 309972 0
waldenstrom's macroglobulinaemia 309973 0
Condition category
Condition code
Cancer 308744 308744 0 0
Leukaemia - Chronic leukaemia
Public Health 308998 308998 0 0
Health service research
Cancer 308999 308999 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SAMSON intervention is aimed at supporting patients who are receiving ibrutinib by improving patient’s adherence to ibrutinib, and reducing problems that may occur when taking medications. This SAMSON research project will assess whether the SAMSON intervention is acceptable to patients taking ibrutinib, the healthcare professionals whom are providing the support via SAMSON, as well as whether this new program can be delivered through the current hospital system.
The intervention arm of the SAMSON project involves receiving an initial face-to-face consultation from a pharmacist to discuss medication understanding, scheduling, and management of adverse side-effects (approx. 30-60 minutes in week 1), five telephone consultations with an intervention nurse to support medication adherence using motivational interviewing techniques, e.g. assistance in identifying and managing barriers to medication adherence (approx. 30-60 minutes each in weeks 2, 3, 6, 10 and 12). Intervention nurses and Research Assistants will contact patients to schedule and remind them of their upcoming teleconsultations.
Patients will also receive a smartphone application (app) that will: 1) send an initial survey about information that the patient may like to know about CLL/SLL/MCL/WM, to complete prior to their first nurse teleconsultation (approx. 10-20 minutes to complete), 2) send daily medication reminders once enrolled in the study, and 3) send a weekly survey to monitor the patient's medication side-effects.
Patients will have the app installed on their smartphones once they have been enrolled into the study and randomised to the intervention group. The app will become active on their smartphone immediately after their their discussion with the pharmacist regarding their medication schedule (dosage), management of side-effects, and potential barriers to medication adherence have been discussed. This discussion occurs during their pharmacy consultation.
Intervention code [1] 312624 0
Behaviour
Comparator / control treatment
The control group will be 'treatment as usual' (standard care) for patients diagnosed with CLL/SLL/MCL/WM who are beginning oral treatment with ibrutinib.
Given that recruitment for this study will take place across five different hospital sites, 'treatment as usual' will vary depending on the patient's individual hospital (i.e. whether they are recruited from: Peter MacCallum Cancer Centre, St Vincent's Hospital, Cabrini Hospital, Box Hill Hospital, and the Austin Hospital).
Control group
Active

Outcomes
Primary outcome [1] 307732 0
Acceptability of the program (smartphone application and nurse/pharmacists teleconsultations) by patients and healthcare professionals.
This will be done via patient and healthcare professional exit interviews. Patient exit interviews will be conducted once their enrolment in the study has concluded (after 6 months). Healthcare professional (nurse and pharmacist) exit interviews will be conducted once the study has concluded (after 2 years).
Timepoint [1] 307732 0
Patient - 6 months post initial session.
Healthcare professional - 2 years post study commencement.
Primary outcome [2] 307962 0
Feasibility of the program to be conducted across different healthcare settings.
This will be done via a cost analysis of data acquired through Medicare and Pharmaceutical Benefits Scheme, and the Australian Refined Diagnosis Related Group data.
Timepoint [2] 307962 0
2 years post study commencement.
Secondary outcome [1] 352684 0
Medication adherence to ibrutinib.
This will be measured via subjective adherence input via the SAMSON smartphone app, and objective adherence input via the medication adherence device that will be attached to the ibrutinib packaging to monitor pill taking activity.
Timepoint [1] 352684 0
Medication adherence will be measured daily throughout the duration of the study.
Secondary outcome [2] 353498 0
Mental health outcome - depression.
This will be measured via the Patient Reported Outcome Measurement Information System (PROMIS). This questionnaire will be administered to all patients.
Timepoint [2] 353498 0
This questionnaire will be administered at baseline, in week 12, and week 25 of the patient's timeline in the study.
Secondary outcome [3] 353510 0
Quality of life.
This will be measured via the EuroQol (5 Dimensions, 5 Level). This questionnaire will be administered to all patients.
Timepoint [3] 353510 0
These questionnaires will be administered at baseline, in week 12, and week 25 of the patient's timeline in the study.
Secondary outcome [4] 353511 0
Side-effects related to ibrutinib.
This survey will only be administered to intervention patients, via the smartphone app.
Timepoint [4] 353511 0
This will be collected via the weekly side-effects survey that was designed specifically for this study.

Eligibility
Key inclusion criteria
1) A confirmed diagnosis of CLL/SLL/MCL/WM and scheduled to commence ibrutinib by treating haematologist/oncologist as part of routine care.
2) No evidence of ibrutinib resistance (as determined by the site investigator).
3) Commencing treatment or currently treated with ibrutinib or treated for <2 months.
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
8) Accessibility to the internet and a smart phone
Minimum age
18 Years
Maximum age
No limit
Sex
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.
3) Adjunct pharmacological treatment for CLL/SLL/MCL/WM (disease specific, not symptom specific)

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site. Holder of the allocation schedule is located at Swinburne University of Technology, which is not a participant recruitment site.
Allocation will also be done via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation: consented participants will be randomised 1:1 to intervention or usual care arms, stratified by site using block randomisation, with blocks of size 4.
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 bias and possible differential attrition will be assessed overall and within sites by comparing demographic and clinical characteristics of adherers and non-adherers using t-tests (or Mann-Whitney) for continuous variables and chi-squared tests for categorical variables. Primary analysis is the proportion of patients who are medically adherent in each arm. This will be assessed using Pearson’s chi-squared test without a continuity correction, and by intention to treat, using multiple imputation to infer missing values and redrawing 50 samples. Several sensitivity analyses will be conducted to corroborate the primary finding. Logistic regression with robust standard errors will be used to assess the effect of the intervention on both observed and imputed data. The
dependent variable is medication adherence and the independent variables will be experimental arm, age, gender, cognitive decline, health beliefs, number of comorbidities, number/complexity of prescribed medication regimen. These analyses will be repeated using per protocol datasets. The Hosmer-Lemeshow statistic will be used to validate all logistic regression models. Multiple linear regression will be used to assess secondary continuous outcomes measured at a single point in time, adjusting for putative confounders. Secondary outcomes measured at two or more points in time will be analysed with linear mixed models. Individual sites will be entered as random effects,
and putative confounders entered as fixed effects. Time will be reparametrised to improve model fit, if necessary, and the significance of these models will be assessed using the arm by group interaction term. Validation of linear regression models will be by standard residual checks for homoscedasticity and normality (at each level). Independence of residuals at different levels will be examined via scatterplot.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
A new study with a broader scope is currently in the planning phase, with anticipated recruitment start in early 2020.
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
1/01/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12130 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 12133 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 12134 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 12135 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [5] 12136 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 24300 0
3000 - Melbourne
Recruitment postcode(s) [2] 24303 0
3084 - Heidelberg
Recruitment postcode(s) [3] 24304 0
3128 - Box Hill
Recruitment postcode(s) [4] 24305 0
3144 - Malvern
Recruitment postcode(s) [5] 24306 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 300885 0
Government body
Name [1] 300885 0
Victorian Cancer Agency
Country [1] 300885 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
PO Box 218
Hawthorn
Victoria 3122 Australia
Country
Australia
Secondary sponsor category [1] 300449 0
None
Name [1] 300449 0
Address [1] 300449 0
Country [1] 300449 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301658 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 301658 0
Ethics committee country [1] 301658 0
Australia
Date submitted for ethics approval [1] 301658 0
08/10/2018
Approval date [1] 301658 0
Ethics approval number [1] 301658 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3151 3151 0 0
/AnzctrAttachments/376158-SAMSON Protocol V1 08-10-18.docx (Protocol)
Attachments [2] 3152 3152 0 0
/AnzctrAttachments/376158-SAMSON-Master Participant Information and Consent Form V1 06-10-18.docx (Participant information/consent)

Contacts
Principal investigator
Name 87690 0
Dr Lisa Grech
Address 87690 0
Peter MacCallum Cancer Centre
Mailbox 93, Locked bag 1
A'Beckett Street, Victoria 8006
Australia
Country 87690 0
Australia
Phone 87690 0
+61 3 8559 7494
Fax 87690 0
Email 87690 0
lgrech@swin.edu.au
Contact person for public queries
Name 87691 0
Lisa Grech
Address 87691 0
Peter MacCallum Cancer Centre
Mailbox 93, Locked bag 1
A'Beckett Street, Victoria 8006
Australia
Country 87691 0
Australia
Phone 87691 0
+61 3 8559 7494
Fax 87691 0
Email 87691 0
lgrech@swin.edu.au
Contact person for scientific queries
Name 87692 0
Lisa Grech
Address 87692 0
Peter MacCallum Cancer Centre
Mailbox 93, Locked bag 1
A'Beckett Street, Victoria 8006
Australia
Country 87692 0
Australia
Phone 87692 0
+61 3 8559 7494
Fax 87692 0
Email 87692 0
lgrech@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not yet received ethics approval for this.


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.