Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07811258

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cancer Behavior Health Behavior Medication Adherence Neoplasms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility, as measured by number of participants recruited

    Time frame: 6 months

    recruitment of 30 patients in 6 months

  2. Feasibility, as measured by screening to enrollment ratio

    Time frame: from screening to enrollment, approximately 2 weeks

    screen to enrollment ratio >30%

  3. 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

  4. Feasibility, as measured by completion rate of the adherence log

    Time frame: 3 months

    80% completion of the adherence log at 3 months

  5. Feasibility, as measured by completion rate of the adherence log

    Time frame: 6 months

    60% completion of the adherence log at 6 months

  6. Acceptability, as measured by Acceptability of Intervention Measure (AIM)

    Time frame: 3 months, 6 months

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Quality of life, as measured by the 36-item Short Form Survey (SF-36)

    Time frame: Baseline, 3 months, 6 months

  2. Financial well-being, as measured by the Comprehensive Score for Financial Toxicity

    Time frame: Baseline, 3 months, 6 months

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.