CancerNCT07811258
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
A study testing Medisafe Medication Management Program and Pharmacist-Led Medication Review in people with Cancer, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Medisafe Medication Management Program and Pharmacist-Led Medication Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- cannot read and communicate in English
- do not have a smartphone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Jhoanna Aquino, 9196606189, jhoannazaida.aquino@duke.edu
About this study
Official title: Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer: A Pilot Study
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.
- Conditions
- Cancer
- Being tested
- Medisafe Medication Management Program, Pharmacist-Led Medication Review
- Keywords
- Medication Adherence, Cancer Survivorship, Multimorbidity
- Medical subject headings
- Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medisafe Medication Management ProgramBehavioural
Training and use of Medisafe application for medication adherence support.
Pharmacist-Led Medication ReviewBehavioural
Comprehensive medication review and education by pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Pharmacist-led medication review plus Medisafe app support. Receives: Behavioral: Medisafe Medication Management Program; Behavioral: Pharmacist-Led Medication Review |
| Control Arm | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by number of participants recruited
recruitment of 30 patients in 6 months
Measured: 6 months
Feasibility, as measured by screening to enrollment ratio
screen to enrollment ratio >30%
Measured: 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
Measured: 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
Measured: 3 months
Feasibility, as measured by completion rate of the adherence log
60% completion of the adherence log at 6 months
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Kaye, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811258
- Sponsor's protocol ID
- Pro00118675
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07811258
- Acronym / sponsor ID
- Pro00118675
- Conditions
- Cancer
- Keywords
- Medication Adherence, Cancer Survivorship, Multimorbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Medisafe Medication Management Program, Behavioral: Pharmacist-Led Medication ReviewPharmacist-led medication review plus Medisafe app support. |
| Control Arm | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- cannot read and communicate in English
- do not have a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medisafe Medication Management ProgramTraining and use of Medisafe application for medication adherence support. | Behavioural | Intervention Arm |
| Pharmacist-Led Medication ReviewComprehensive medication review and education by pharmacist. | Behavioural | Intervention Arm |
Primary outcome
Feasibility, as measured by number of participants recruited
Time frame: 6 months
recruitment of 30 patients in 6 months
Feasibility, as measured by screening to enrollment ratio
Time frame: from screening to enrollment, approximately 2 weeks
screen to enrollment ratio >30%
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
Feasibility, as measured by completion rate of the adherence log
Time frame: 3 months
80% completion of the adherence log at 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
Acceptability, as measured by Acceptability of Intervention Measure
Time frame: 3 months, 6 months
5-point scale ranging from 1 (completely disagree) to 5 (completely agree). Higher scores indicating greater acceptability of the intervention.
Usability, as measured by the System Usability Score of the Medisafe application
Time frame: 3 months, 6 months
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).
Patient-centeredness, as measured by the Patient-Centered Care Questionnaire
Time frame: 3 months
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.
Patient-centeredness, as measured by the Patient-Centered Outcomes Questionnaire
Time frame: 3 months
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.
4 secondary outcomes
Quality of life, as measured by the 20-item Short Form Survey
Time frame: Baseline, 3 months, 6 months
Financial well-being, as measured by the Comprehensive Score for Financial Toxicity
Time frame: Baseline, 3 months, 6 months
Patient activation, as measured by the Patient Activation Measure
Time frame: Baseline, 3 months, 6 months
Adherence, as measured by the Adherence to Refills Medication Scale
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Kaye principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medisafe Medication Management Program and Pharmacist-Led Medication Review in people with Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by number of participants recruited (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.