About this trial
This pilot study evaluates a pharmacist-led medication adherence intervention and Medisafe mobile application among patients with newly diagnosed cancer and multimorbidity. Thirty participants will be randomized to intervention or usual care to assess feasibility, acceptability, usability, and preliminary efficacy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with breast, colorectal, lung or prostate cancer in the previous 12 months
had no prior diagnosis of cancer
are currently undergoing chemotherapy or radiation and/or underwent surgery in the prior 3 months
had >2 chronic conditions for >1 year prior to cancer diagnosis
Disqualifiers
cannot read and communicate in English
do not have a smartphone
Trial design
Parallel
Treatments tested in this trial
Medisafe Medication Management Program
BehavioralTraining and use of Medisafe application for medication adherence support.
Pharmacist-Led Medication Review
BehavioralComprehensive medication review and education by pharmacist.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility, as measured by number of participants recruited
recruitment of 30 patients in 6 months
Feasibility, as measured by screening to enrollment ratio
screen to enrollment ratio \>30%
Feasibility, as measured by completion rate of the comprehensive medication review
60% completion of the comprehensive medication review
Feasibility, as measured by completion rate of the adherence log
80% completion of the adherence log at 3 months
Secondary outcomes
Quality of life, as measured by the 20-item Short Form Survey
Uses a 0% to 100% scale where higher scores always indicate better health.
Financial well-being, as measured by the Comprehensive Score for Financial Toxicity
Each question is answered on a 0 to 4 scale. The lower numbers indicate worse (more severe) financial toxicity, while higher numbers indicate better financial well-being.
Patient activation, as measured by the Patient Activation Measure
Patient Activation Measure evaluates the patient's knowledge, skill, and confidence in managing their health, focusing on how engaged patients are in their care and whether they feel empowered in decision-making processes. Each of the 10 statements is scored form 1 (strongly disagree) to 4 (strongly agree). Higher scores show greater patient empowerment and engagement.
Adherence, as measured by the Adherence to Refills Medication Scale
Adherence to Refills Medication Scale , a validated survey on barriers to adherence, and logs obtained from the Medisafe mobile application. Uses a 4-point scale, 1 (none of the time) to 4 (all of the time) where lower scores show better adherence and fewer barriers.
Locations
Sponsors and contacts
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