An interventional study of Medisafe Medication Management Program and Pharmacist-Led Medication Review in Cancer, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pharmacist-led medication review plus Medisafe app support.
Behavioral: Medisafe Medication Management Program · Behavioral: Pharmacist-Led Medication Review
Usual care.
Training and use of Medisafe application for medication adherence support.
Comprehensive medication review and education by pharmacist.
Feasibility, as measured by number of participants recruited
recruitment of 30 patients in 6 months
Time frame: 6 months
Feasibility, as measured by screening to enrollment ratio
screen to enrollment ratio \>30%
Time frame: from screening to enrollment, approximately 2 weeks
Feasibility, as measured by completion rate of the comprehensive medication review
60% completion of the comprehensive medication review
Time frame: from enrollment to completion of 6 month follow up
Feasibility, as measured by completion rate of the adherence log
80% completion of the adherence log at 3 months
Time frame: 3 months
Feasibility, as measured by completion rate of the adherence log
60% completion of the adherence log at 6 months
Time frame: 6 months
Acceptability, as measured by Acceptability of Intervention Measure
5-point scale ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicating greater acceptability of the intervention.
Time frame: 3 months, 6 months
Usability, as measured by the System Usability Score of the Medisafe application
The System Usability Score is a 10-item questionnaire that has been validated for mobile applications. This scales all values from 0 to 4 (with four being the most positive response).
Time frame: 3 months, 6 months
Patient-centeredness, as measured by the Patient-Centered Care Questionnaire
The Patient-Centered Care Questionnaire assesses the extent to which care delivery aligns with the core principles of patient-centered care and includes dimensions like respect for patient preferences, emotional support, and physical comfort. The response options are scored from 1 to 5, with higher scores representing better outcome.
Time frame: 3 months
Patient-centeredness, as measured by the Patient-Centered Outcomes Questionnaire
The Patient-Centered Outcomes Questionnaire measures whether healthcare interventions address the issues patients consider most important. It emphasizes outcomes that matter most to patients, such as symptom relief, quality of life, and emotional well-being. The response options are scored from 1 to 5, with higher scores representing better outcome.
Time frame: 3 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: Baseline, 3 months, 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 7 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 30, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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