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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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