Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Medisafe Medication Management Program

    Behavioral

    Training and use of Medisafe application for medication adherence support.

  • Pharmacist-Led Medication Review

    Behavioral

    Comprehensive medication review and education by pharmacist.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 2 interventions
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility, as measured by number of participants recruited

recruitment of 30 patients in 6 months

Time frame
6 months
2

Feasibility, as measured by screening to enrollment ratio

screen to enrollment ratio \>30%

Time frame
from screening to enrollment, approximately 2 weeks
3

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
4

Feasibility, as measured by completion rate of the adherence log

80% completion of the adherence log at 3 months

Time frame
3 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: