Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer: A Pilot Study

September 3, 2026 updated by: Duke University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Usual care.
Experimental: Intervention Arm
Pharmacist-led medication review plus Medisafe app support.
Behavioral: Medisafe Medication Management Program
Training and use of Medisafe application for medication adherence support.
Behavioral: Pharmacist-Led Medication Review
Comprehensive medication review and education by pharmacist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility, as measured by number of participants recruited
Time Frame: 6 months
recruitment of 30 patients in 6 months
6 months
Feasibility, as measured by screening to enrollment ratio
Time Frame: from screening to enrollment, approximately 2 weeks
screen to enrollment ratio >30%
from screening to enrollment, approximately 2 weeks
Feasibility, as measured by completion rate of the comprehensive medication review
Time Frame: from enrollment to completion of 6 month follow up
60% completion of the comprehensive medication review
from enrollment to completion of 6 month follow up
Feasibility, as measured by completion rate of the adherence log
Time Frame: 3 months
80% completion of the adherence log at 3 months
3 months
Feasibility, as measured by completion rate of the adherence log
Time Frame: 6 months
60% completion of the adherence log at 6 months
6 months
Acceptability, as measured by Acceptability of Intervention Measure (AIM)
Time Frame: 3 months, 6 months
3 months, 6 months
Usability, as measured by the System Usability Score of the Medisafe application
Time Frame: 3 months, 6 months
The SUS is a 10-item questionnaire that has been validated for mobile applications.
3 months, 6 months
Patient-centeredness, as measured by the Patient-Centered Care Questionnaire (PCCQ)
Time Frame: 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.
3 months
Patient-centeredness, as measured by the Patient-Centered Outcomes Questionnaire (PCOQ)
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life, as measured by the 36-item Short Form Survey (SF-36)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Financial well-being, as measured by the Comprehensive Score for Financial Toxicity
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Patient activation, as measured by the Patient Activation Measure (PAM)
Time Frame: 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.
Baseline, 3 months, 6 months
Adherence, as measured by the Adherence to Refills Medication Scale (ARMS)
Time Frame: 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.
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Deborah Kaye, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 7, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00118675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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