None listed
Conditions
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.
Interventions
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 patie
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.
Sponsors
Australasian Leukaemia and Lymphoma Group
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 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
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.
Outcome results
None listed