Clinical trial NCT05225090: Smartphone App for Cancer Medication Adherence
Official title: Trial of a Smartphone Application to Improve Medication Adherence Among Patients with Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma
Cancer
Keywords: any stage
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: For this current proposal, the investigator will conduct a single-center prospective non-randomized pilot interventional study in patients with any stage and type of cancer who are either taking at least one OACD or are taking at least one oral medication for chronic condition management in conjunction with any cancer treatment.

Primary Objective: To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients either receiving oral anticancer agents (OACDs) or receiving oral medications for chronic disease management (non-OACDs) in conjunction with non-oral cancer treatment.

Secondary Objectives: To compare and characterize medication adherence before and after the 12-week intervention using the Voils Extent of Adherence Scale and the Medisafe App. Also to determine the acceptability, utility and patient engagement with the App, to evaluate changes in healthcare related quality of life before and after the intervention, and to explore behaviors, knowledge, attitudes and beliefs related to medication adherence using a semi-structured interview delivered over the telephone.

Detailed description: Many patients with cancer experience frustration with the large number and complex scheduling of their medications. This study will help find out how much "pill burden" exists in patients with cancer, and how a smartphone app can help patients take medications as providers prescribe. Results of this study may help figure out the best way to help patients manage medications in the future.

Eligibility criteria: Inclusion Criteria:

* Any type/stage cancer
* Patients must be taking either:

  * at least one oral anti-cancer drug (OACD) or
  * at least one oral medication (non-OACD) for management of a chronic condition in addition to receiving non-oral cancer treatment
* Patients must have access to a mobile phone or tablet that can download the Medisafe App. (ie apple/android)
* Subjects must be able to complete self-administered questionnaires in English or Spanish.
* Co-enrollment in trials involving pharmacologic therapy is allowed.

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Proportion of subjects enrolled that complete the 12-week intervention and assessments
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in mean score on the Voils Extent of Adherence Scale for oral caner therapy use between baseline and 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change in mean score on the Voils Extent of Adherence Scale for global medication use between baseline and 12 weeks
timeFrame: Baseline and 12 weeks
measure: Mean Score to Medication Self-Efficacy Scale (MASES) to assess a patient's confidence in their ability to take their medications in a variety of situations
timeFrame: 12 weeks
measure: Mean Score on the User Version of the Mobile Application Rating Scale
timeFrame: 12 weeks
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Score before and after the intervention
timeFrame: Baseline and 12 weeks
measure: Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Score before and after the intervention
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Medicine
name: Melissa Accordino, MD
role: PRINCIPAL_INVESTIGATOR
References: