Safety and adherence to medications and self-care advice in oncology (SAMSON): pilot randomised controlled trial protocol.

INTRODUCTION: With the increasing use of oral anti-cancer medicines (OAMs), research demonstrating the magnitude of the medication non-adherence problem and its consequences on treatments' efficacy and toxicity is drawing more attention. Mobile phone interventions may be a practical solution to support patients taking OAMs at home, yet evidence to inform the efficacy of these interventions is lacking. The safety and adherence to medications and self-care advice in oncology (SAMSON) pilot randomised control trial (RCT) aims to evaluate the acceptability, feasibility and potential efficacy of a novel digital solution to improve medication adherence (MA) among people with cancer. METHODS AND ANALYSIS: This is a two-arm, 12-week, pilot RCT aiming to enrol 50 adults with haematological, lung or melanoma cancers at an Australian metropolitan specialised oncology hospital, who are taking oral anti-cancer medicines. Participants will be randomised (1:1 allocation ratio) to either the intervention group (SAMSON solution) or the control group (usual care). The primary outcomes are the acceptability and feasibility of SAMSON. The secondary outcomes are MA, toxicity self-management, anxiety and depressive symptoms, health-related quality of life, and parameters relating to optimal intervention strategy. Quantitative data will be analysed on a modified intention-to-treat basis. SUMMARY: While multicomponent interventions are increasingly introduced, SAMSON incorporates novel approaches to the solution. SAMSON provides a comprehensive, patient-centred, digital MA intervention solution with seamless integration of a mobile platform with clinical consultations that are evidence-based, theory-based, co-designed and rigorously tested. The pilot trial will determine whether this type of intervention is feasible and acceptable in oncology and will provide a foundation for a future full-scale RCT. ETHICS AND DISSEMINATION: Primary ethics approvals were received from Peter MacCallum Cancer Centre and Swinburne University of Technology Human Research Ethics Committees (HREC/95332/PMCC and 20237273-15836). Results will be disseminated via peer-reviewed publications and presentations at international and national conferences. TRIAL REGISTRATION NUMBER: The protocol has been prospectively registered on the Australian New Zealand Clinical Trials Registry with trial registration number (ACTRN12623000472673).

Post-surgical discharge opioid prescribing, use and handling after introduction of a stewardship program.

SummaryOpioids are often used to provide postsurgical analgesia but may cause harm if used inappropriately. We introduced an opioid stewardship program in three Melbourne hospitals to reduce the inappropriate use of opioids after patient discharge. The program had four pillars: prescriber education, patient education, a standardised quantity of discharge opioids, and general practitioner (GP) communication. Following introduction of the program, we undertook this prospective cohort study. The study aimed to describe post-program discharge opioid prescribing, patient opioid use and handling, and the impact of patient demographics, pain and surgical treatment factors on discharge prescribing. We also evaluated compliance with the program components. We recruited 884 surgical patients from the three hospitals during the ten-week study period. Discharge opioids were dispensed to 604 (74%) patients, with 20% receiving slow-release opioids. Junior medical staff undertook 95% of discharge opioid prescribing, which was guideline-compliant for 78% of patients. Of the patients discharged with opioids, a GP letter was sent for only 17%. Follow-up at two weeks was successful in 423 (70%) patients and in 404 (67%) at three months. At the three-month follow-up, 9.7% of patients reported ongoing opioid use; in preoperatively opioid naïve patients, the incidence was 5.5%. At the two-week follow-up, only 5% reported disposal of excess opioids, increasing to 26% at three months. Ongoing opioid therapy at three months in our study cohort (9.7%; 39/404) was associated with preoperative opioid consumption and higher pain scores at the three-month follow-up. The introduction of the opioid stewardship program resulted in highly guideline-compliant prescribing, but hospital-to-GP communication was uncommon and opioid disposal rates were low. Our findings suggest that opioid stewardship programs can improve postoperative opioid prescribing, use and handling, but the realisation of these gains will require effective program implementation.

Potential issues with complementary medicines commonly used in the cancer population: A retrospective review of a tertiary cancer center's experience.

AIM: Complementary medicine (CAM) use in the cancer population is higher than the general population: some studies estimate up to 70%. Our Medicines Information Centre, in a tertiary cancer institution, receives many enquiries regarding use and safety of CAM with conventional cancer therapies (chemotherapy, radiotherapy and surgery). This project aims to review the CAM most commonly enquired about with an emphasis on potential interactions with conventional cancer therapies. METHODS: An audit and review of CAM enquiries from patients or medical professionals at our center, over a 2-year period (July 2011-June 2013), was conducted. The most commonly enquired about CAM, excluding vitamins and minerals, were identified, reviewed and potential interactions described. RESULTS: Enquiries were received from 462 patients involving 330 different CAMs. The 10 CAMs most commonly enquired about were fish oil (3.54%), turmeric (3.24%), coenzyme Q10 (2.63%), milk thistle (2.44%), green tea (2.38%), ginger (2.14%), lactobacillus (2.08%), licorice (1.83%), astragalus (1.77%) and reishi mushroom (1.59%). All were found to have predicted or potential drug interactions or therapeutic issues when combined with conventional therapies. Human studies are lacking and potential drug interactions are often predicted using in vitro or in vivo animal data. CONCLUSIONS: While many CAMs may be safe when taken by themselves, there is theoretically a potential for interactions and/or increased risk of serious adverse effects when taken concurrently with conventional anticancer therapies. The paucity of human data implies that their clinical significance is difficult to quantify and hence caution is required.

A case of delayed methotrexate clearance following administration of a complementary medication containing chlorophyll.

A 54-year-old male with relapsed primary cerebral lymphoma and normal renal function was treated with methotrexate (MTX) 3 g/m(2) monthly by intravenous infusion. Throughout treatment the patient self-administered a complementary medicine (Jason Winter's chlorophyll®), which he was advised to cease during methotrexate treatment due to the potential for unknown interactions. For the first four cycles, chlorophyll was ceased two days prior to commencement of methotrexate and withheld until clearance. These cycles were administered without complication, and the methotrexate level reduced to <0.05 µmol/L within three days of each dose. Prior to cycle 5, chlorophyll was not ceased and there were no changes to concomitant medications. A literature search found no documented interactions between methotrexate and chlorophyll and the chemotherapy was administered without a delay in treatment. The methotrexate level three days post-administration was 0.36 µmol/L and did not reduce to <0.05 µmol/L until day 10. Consequently, from cycles 6 to 12, the methotrexate dose was halved, and the patient ceased chlorophyll 48 h prior to methotrexate administration until clearance. There were no further episodes of delayed methotrexate clearance. No impurities were detected in a sample of Jason Winter's chlorophyll®. It is therefore likely that the patient's delayed methotrexate clearance was due to an interaction with chlorophyll. It is recommended that such chlorophyll containing preparations be avoided in patients treated with methotrexate.