None listed
Conditions
Brief summary
This trial will assess the acceptability, feasibility and potential efficacy of the SAMSON digital platform, which is designed to support patients who are taking oral cancer medications by targeting their medication adherence to the treatment and medication errors. Who is it for? You may be eligible for this study if you are aged 18 years or over and have received a confirmed diagnosis of any-stage haematological, lung or melanoma cancer, for which you are 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. Study details Participants will be randomly assigned to either the SAMSON intervention group or a standard-of-care group over the 12-week study period. Those in the intervention group will receive access to the SAMSON apps which record medication adherence and side effects, as well as structured counselling sessions with healthcare professionals at the beginning for the study and weeks 1, 4, 8 and 12. Those in the standard-of-care group will receive usual care, including a clinician consultation, initial pharmacist consultation and be followed-up by a nurse for medication side effects. Participants will be asked to complete surveys over the course of the study. It is hoped that this research will help provide an effective way of managing medications during cancer treatment.
Interventions
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 not
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.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed