None listed
Conditions
Brief summary
The purpose of this study is to assess the feasibility and acceptability of a pharmacist and nurse-led intervention to help management of medication in people taking ibrutinib. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with chronic lymphocytic leukaemia, small lymphocytic lymphoma, mantle cell lymphoma or walenstrom’s macroglobulinaemia and are scheduled to commence ibrutinib as part of your usual care. Study details Participants will be randomly allocated to one of two groups. One group will receive usual care including standard medication management. The other group will receive a face-to-face consultation with a pharmacist to discuss their medication, and complete five phone calls with a nurse over 12 weeks to assist with taking medication as prescribed by their doctor. Participants in the second group will also use a phone app that will provide daily medication reminders, and access to advice on how to manage any side-effects. All participants will also complete questionnaires relating to their health and complete routine blood tests. It is hoped that this research will help provide an effective way of managing medications during cancer treatment.
Interventions
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
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.
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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)
Outcome results
None listed