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

NCT07811258 | Not Yet Recruiting

• 1 other identifier: Pro00118675
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

Medication Adherence; Cancer Survivorship; Multimorbidity

Outcome Measures

Primary Outcomes (9)

• Feasibility, as measured by number of participants recruited

  recruitment of 30 patients in 6 months

  6 months

• Feasibility, as measured by screening to enrollment ratio

  screen to enrollment ratio \>30%

  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

  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

  3 months

• Feasibility, as measured by completion rate of the adherence log

  60% completion of the adherence log at 6 months

  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.

  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).

  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.

  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.

  3 months

Secondary Outcomes (4)

• Quality of life, as measured by the 20-item Short Form Survey

  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

  Baseline, 3 months, 6 months

• Adherence, as measured by the Adherence to Refills Medication Scale

  Baseline, 3 months, 6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Pharmacist-led medication review plus Medisafe app support.

Behavioral: Medisafe Medication Management Program; Behavioral: Pharmacist-Led Medication Review

Control Arm

NO INTERVENTION

Usual care.

Interventions

Medisafe Medication Management Program BEHAVIORAL

Training and use of Medisafe application for medication adherence support.

Intervention Arm

Pharmacist-Led Medication Review BEHAVIORAL

Comprehensive medication review and education by pharmacist.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• cannot read and communicate in English
• do not have a smartphone

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Deborah Kaye

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 10, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share