Cancer
Conditions
Keywords
Medication Adherence, Cancer Survivorship, Multimorbidity
Brief summary
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.
Interventions
BEHAVIORALMedisafe Medication Management Program
Training and use of Medisafe application for medication adherence support.
BEHAVIORALPharmacist-Led Medication Review
Comprehensive medication review and education by pharmacist.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * are prescribed \>1 non-cancer medication(s)
Exclusion criteria
* cannot read and communicate in English * do not have a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, as measured by number of participants recruited | 6 months | recruitment of 30 patients in 6 months |
| Feasibility, as measured by screening to enrollment ratio | from screening to enrollment, approximately 2 weeks | screen to enrollment ratio \>30% |
| Feasibility, as measured by completion rate of the comprehensive medication review | from enrollment to completion of 6 month follow up | 60% completion of the comprehensive medication review |
| Feasibility, as measured by completion rate of the adherence log | 3 months | 80% completion of the adherence log at 3 months |
| Acceptability, as measured by Acceptability of Intervention Measure (AIM) | 3 months, 6 months | — |
| Usability, as measured by the System Usability Score of the Medisafe application | 3 months, 6 months | The SUS is a 10-item questionnaire that has been validated for mobile applications. |
| Patient-centeredness, as measured by the Patient-Centered Care Questionnaire (PCCQ) | 3 months | PCCQ 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. |
| Patient-centeredness, as measured by the Patient-Centered Outcomes Questionnaire (PCOQ) | 3 months | PCOQ 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life, as measured by the 36-item Short Form Survey (SF-36) | Baseline, 3 months, 6 months | — |
| Financial well-being, as measured by the Comprehensive Score for Financial Toxicity | Baseline, 3 months, 6 months | — |
| Patient activation, as measured by the Patient Activation Measure (PAM) | Baseline, 3 months, 6 months | PAM 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. |
| Adherence, as measured by the Adherence to Refills Medication Scale (ARMS) | Baseline, 3 months, 6 months | Adherence to Refills Medication Scale (ARMS), a validated survey on barriers to adherence, and logs obtained from the Medisafe mobile application. |
Contacts
PRINCIPAL_INVESTIGATORDeborah Kaye
Duke University
Outcome results
None listed