Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000472673
Ethics application status
Approved
Date submitted
17/04/2023
Date registered
9/05/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
9/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to test the acceptability, feasibility and potential efficacy of the SAMSON solution for medication adherence in cancer
Scientific title
Pilot randomized controlled trial (RCT) to test the acceptability, feasibility and potential efficacy of the SAMSON (Safety and Adherence to Medications and Self-care advice in Oncology) intervention solution in adults with haematological, lung or melanoma cancers (Short title: SAMSON pilot RCT)
Secondary ID [1] 309434 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 329689 0
Condition category
Condition code
Cancer 326585 326585 0 0
Leukaemia - Chronic leukaemia
Cancer 326586 326586 0 0
Malignant melanoma
Cancer 326635 326635 0 0
Other cancer types
Cancer 326742 326742 0 0
Lung - Mesothelioma
Cancer 326743 326743 0 0
Hodgkin's
Cancer 326744 326744 0 0
Myeloma
Cancer 326745 326745 0 0
Lung - Non small cell
Cancer 326746 326746 0 0
Lung - Small cell
Cancer 326747 326747 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 326748 326748 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SAMSON intervention solution consists of two synergistic operating elements:
1) SAMSON mobile platform, including smartphone-based app and to remotely prompt medication adherence (MA), monitor patient side-effects and deliver self-care advice; and computer-based app to enable adherence and side-effect reporting.
- Patients will have the app installed on their smartphones once they have been enrolled into the study and randomised to the intervention group.
- They will receive daily push notifications to prompt MA and weekly side effect surveys to monitor their symptoms. It would take them about five minutes per week over the 12-week study period to respond to notifications and complete the survey.
- The self-care advice on common side effects is available on the 'side effects' tab in the smart-phone app.
- Participants' responses to the notifications and side effects surveys are analysed and reported on the web page. Based on this information, the healthcare professionals (HCPs) will provide consultations to encourage patients' adherence.
2) HCPs provide consultations, using motivational interviewing (MI) skills being trained via the motivational interviewing training platform (MITP) to promote patient’s adherence and side-effect self-management by:
o Medication reconciliation,
o MA education,
o Medication administration, missed dose and side-effect education, including side-effect management strategies,
o Assessment of barriers and concerns
- The structured counselling sessions will be either in person or phone or online at baseline, week 1, 4, 8 and 12.
- The initial (baseline) consultation will be delivered by a pharmacist to discuss medication understanding, scheduling and management of adverse effects (approx. 30-60 minutes). The four following consultations will be delivered by a nurse or a pharmacist to support MA using MI techniques, e.g. assistance in identifying and managing barriers to MA (approx. 15-30 minutes each). The length of consultations will be tailored to each patient’s need and adherence status, assessed by the HCP who delivers the counselling sessions.
- A consultation checklist will be completed by the HCP after each session. It is used to informed the next consultation session.
- The HCP will also send brief consultation notes to the patient for follow-up.
Intervention code [1] 325897 0
Treatment: Other
Intervention code [2] 325975 0
Behaviour
Comparator / control treatment
The standard care at Peter Mac often involves:
- A consultation in the clinic with the clinic clinician, to provide education about medication, and patient-focused management of side-effects including the appropriate action to take regarding serious side-effects (e.g. when/where to seek urgent medical attention). The disease stream nurse will be the patient’s ongoing contact for the management of any side-effects related to their treatment medication. The length of this consultation is varied, depending on the clinical requirement, often approx. 15-30 minutes.
- An initial pharmacist consultation at Peter Mac for the patient who chooses to fill their prescription at Peter Mac. This consultation often happens right after the clinician consultation or during the first following week. In this consult, a medication reconciliation and medication dispensary consultation is conducted with a pharmacist to catalogue the patient’s prescription and non-prescription medications (including new medications), identify any contraindications, adverse drug reactions, provide administration instructions for each medication schedule, confirm that administration instructions have been understood, and address any patient concerns regarding their medication or medication schedules (approx 10-15 minutes).
- A follow-up call after commencing medication will be undertaken within 1-2-weeks by the disease stream nurse for assessment of early toxicity (approx. 10-15 minutes).
Control group
Active

Outcomes
Primary outcome [1] 334501 0
Acceptability measured by a questionnaire, guided by the Unified Theory of Acceptance and Use of Technology (UTAUT)
Timepoint [1] 334501 0
Week 12 post-commencement of intervention
Primary outcome [2] 334502 0
Feasibility measured both quantitatively and qualitatively throughout the study, including recruitment, randomisation, retention, intervention adherence, and assessment processes. For intervention patients, responses to weekly side effects surveys and daily medication reminders will also be measured.
- Information on recruitment, randomisation and retention will be recorded in the participant spreadsheet, including the reason for participants not to provide consent or withdraw from the study.
- Information on patients' adherence to the intervention, e.g. responding to the daily notifications and weekly surveys will be assessed by the SAMSON app analytics and reported on the web page.
- Information on the outcome assessments will be analysed based on the proportion of participants completed each assessment on REDCap.
Timepoint [2] 334502 0
- Recruitment, randomisation and retention: upon conclusion of the study
- Responses to drug notifications: daily over 12-week study period
- Responses to side effects surveys: weekly over 12-week study period
- Outcome assessments: Week 1 and Week 12 for all participants (ASK-12, PAM-SF, PROMIS and FACT-G). Week 12 for participants in the intervention arm and HCPs (UTAUT). Week 16 (medication refills adherence-MRA)
Secondary outcome [1] 420904 0
Medication adherence measured by medication refill adherence (MRA). Pharmacy dispensing data (Merlin) will be used to determine MRA, defined as the total days’ supply divided by the number of days of study participation and multiplied by 100. Data will be extracted at a single time point once the last patient has reached week 16. Data will be extracted by pharmacy as part of collaboration in this research program.
Timepoint [1] 420904 0
Week 16 post-commencement of intervention
Secondary outcome [2] 420905 0
Self-report adherence measured by Adherence Starts with Knowledge-12 (ASK-12)
Timepoint [2] 420905 0
Weeks 1 and 12 post-commencement of intervention
Secondary outcome [3] 420906 0
Toxicity Self-management measured by the Patient Activation Measure-Short Form (PAM-SF)
Timepoint [3] 420906 0
Weeks 1 and 12 post-commencement of intervention
Secondary outcome [4] 420907 0
Anxiety, Depression and Symptoms will be assessed as a composite outcome, measured by Patient-Reported Outcomes Measurement Information System (PROMIS) scales
Timepoint [4] 420907 0
Weeks 1 and 12 post-commencement of intervention
Secondary outcome [5] 420908 0
Quality of Life measured by the Functional Assessment of Cancer Therapy–General (FACT-G)
Timepoint [5] 420908 0
Weeks 1 and 12 post-commencement of intervention
Secondary outcome [6] 420909 0
Optimal intervention strategy will be measured by qualitative questions in the UTAUT survey
Timepoint [6] 420909 0
Week 12 post-commencement of intervention

Eligibility
Key inclusion criteria
1) A confirmed diagnosis of any-stage haematological, lung or melanoma cancer;
2) Scheduled to commence oral anti-cancer treatment as part of routine care or commencing treatment/currently treated with the medication for less than 12 months;
3) Willing to have oral anti-cancer medication dispensed at Peter Mac;
4) 18 years or over;
5) Proficient in English; and
6) Accessibility to the internet and a smartphone and/or computer and telehealth.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Too unwell to participate in the study as determined by the patient’s treatment team.
2) Remaining indication treatment period of oral medications for cancer therapy is less than 12 weeks.
3) 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.

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)
Following consent, the study statistician, located at Swinburne University, will randomise participants 1:1 in blocks of 4 to intervention or usual care arms and send by email to the research coordinator (RC) who will arrange participants to the arm specified in the email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
5/08/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
28/02/2024
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
50
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24551 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 40145 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 313629 0
Hospital
Name [1] 313629 0
Peter MacCallum Cancer Centre (Peter Mac)
Country [1] 313629 0
Australia
Funding source category [2] 313669 0
University
Name [2] 313669 0
Swinburne University of Technology
Country [2] 313669 0
Australia
Funding source category [3] 313670 0
Government body
Name [3] 313670 0
Digital Health Cooperative Research Centre
Country [3] 313670 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne VIC 3000, Australia
Country
Australia
Secondary sponsor category [1] 315423 0
None
Name [1] 315423 0
Address [1] 315423 0
Country [1] 315423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312800 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 312800 0
Ethics committee country [1] 312800 0
Australia
Date submitted for ethics approval [1] 312800 0
09/03/2023
Approval date [1] 312800 0
06/06/2023
Ethics approval number [1] 312800 0
HREC/95332/PMCC
Ethics committee name [2] 312835 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [2] 312835 0
Ethics committee country [2] 312835 0
Australia
Date submitted for ethics approval [2] 312835 0
01/05/2023
Approval date [2] 312835 0
Ethics approval number [2] 312835 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125970 0
Prof Penelope Schofield
Address 125970 0
Department of Psychological Sciences
Iverson Health Innovation Research Institute
Swinburne University of Technology
Mail H99, PO Box 218, Hawthorn, VIC 3122
Country 125970 0
Australia
Phone 125970 0
+61 3 9214 4886
Fax 125970 0
Email 125970 0
[email protected]
Contact person for public queries
Name 125971 0
Thu Ha Dang
Address 125971 0
Department of Psychological Sciences
Swinburne University of Technology
Mail H99, PO Box 218, Hawthorn, VIC 3122
Country 125971 0
Australia
Phone 125971 0
+61 422703347
Fax 125971 0
Email 125971 0
[email protected]
Contact person for scientific queries
Name 125972 0
Thu Ha Dang
Address 125972 0
Department of Psychological Sciences
Swinburne University of Technology
Mail H99, PO Box 218, Hawthorn, VIC 3122
Country 125972 0
Australia
Phone 125972 0
+61 422703347
Fax 125972 0
Email 125972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.