CarcinomaNCT05225090

Smartphone App for Cancer Medication Adherence

A study testing Smartphone App in people with Carcinoma and Cancer, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Cancer
What is being tested?: Smartphone App
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2020to 31 May 2024
Phase: Interventional
Are there results?: None posted in the registry

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

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.

Who cannot join

Inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: Trial of a Smartphone Application to Improve Medication Adherence Among Patients with Cancer

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.

Read the 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.

Conditions: Carcinoma, Cancer
Being tested: Smartphone App
Keywords: any stage
Medical subject headings: Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smartphone AppOther
Also called Medisafe App
Medisafe is a Med_App that is free and has been used in several studies evaluating medication adherence. Patients will receive individualized instruction and be followed for 12 weeks. The researcher will show the patients how to input current medication list, set up medication reminders and track if daily doses have been taken using the App (20 minute training session). After the participant has input their medication information into the app, the researcher will assist the participant in adding an optional "Medifriend" who will be alerted if the participant misses a dose as an option. The participant will also be provided with written instructions about the Medisafe app to take home for reference. At each office visit (4, 8, and 12 weeks) participants will complete a medication checklist and reconciliation form with the research staff. Participants will also be asked to send a medication status report through the Medisafe app.

Study groups in NCT05225090
Study group	Role	What they receive
Smartphone App Intervention	Other	Cancer patients taking at least one oral anti-cancer drug or oral medication to manage a chronic condition in conjunction with any cancer treatment will receive messages through the Medisafe App. Receives: Other: Smartphone App

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects enrolled that complete the 12-week intervention and assessments
To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients. Feasibility defined as completing the 12-week intervention and the endpoint assessments. Patients will be tallied.
Measured: 12 weeks

Secondary outcomes (6)

Change in mean score on the Voils Extent of Adherence Scale for oral caner therapy use between baseline and 12 weeks
To compare medical adherence to OACDs before and after the 12-week intervention using the Voils Extent of Adherence Scale for OACD use. The Extent of Adherence subscale of the Voils Self-Reported Medication Nonadherence Measurement (Voils Measure) will be used for self-assessment of drug adherence. The Extent of Adherence subscale of the Voils Measure consists of three questions with responses ranging from 1 (perfect adherence) to 5 (highest degree of nonadherence). The Extent score can be calculated in two different ways: the three items in the Extent scale can be averaged, with higher scores representing greater nonadherence, or the scale can be dichotomized, such that perfect adherence is considered "adherent", and any degree of nonadherence is considered "nonadherent."
Measured: Baseline and 12 weeks
Change in mean score on the Voils Extent of Adherence Scale for global medication use between baseline and 12 weeks
To compare medical adherence to OACDs before and after the 12-week intervention using the Voils Extent of Adherence Scale for OACD use. The Extent of Adherence subscale of the Voils Self-Reported Medication Nonadherence Measurement (Voils Measure) will be used for self-assessment of drug adherence. The Extent of Adherence subscale of the Voils Measure consists of three questions with responses ranging from 1 (perfect adherence) to 5 (highest degree of nonadherence). The Extent score can be calculated in two different ways: the three items in the Extent scale can be averaged, with higher scores representing greater nonadherence, or the scale can be dichotomized, such that perfect adherence is considered "adherent", and any degree of nonadherence is considered "nonadherent." For this study, global adherence will be defined as a perfect score (1) for each medication.
Measured: Baseline and 12 weeks
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
The Medication Self-Efficacy Scale (MASES) is a tool used to assess a patient's confidence in their ability to take their medications in a variety of situations. This is a 25-item scale and items are scored 1= not sure at all, to 4= very sure, and the total scores of the measure is the mean response to all the items (range 1-4).
Measured: 12 weeks
Mean Score on the User Version of the Mobile Application Rating Scale
The User Version of the Mobile Application Rating Scale (uMARS) is a 20-item tool used for classifying and assessing the quality of mobile health apps. It contains four objective quality subscales including engagement, functionality, aesthetics, and information quality. Each of the 20-items have an outcome of 1-5; the overall outcome scale ranges from 20-100. It has been developed and validated specifically for end user administration.
Measured: 12 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Score before and after the intervention
The Patient-Reported Outcomes Measurement Information System (PROMIS) 29 is a well- validated assessment tool that offers both qualitative and quantitative measures of health-related quality of life. The PROMIS-29 includes 29 questions evaluating areas of physical function, anxiety, depression, fatigue, sleep, social functioning, and pain interference. The PROMIS-29 assesses severity levels of symptoms and their effect on the patient's functioning.
Measured: Baseline and 12 weeks
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Score before and after the intervention
The 14-item TSQM Version 1.4 is a reliable and valid instrument to assess patients' satisfaction with medication, providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. We will use the validated abbreviated TSQM-9.24 This questionnaire includes 9-items that address six different domains which include domains of TS-M included; (1) side effects, (2) symptom relief, (3) convenience, (4) effectiveness, (5) impact on daily life, and (6) tolerability/acceptability. Scoring of the TSQM-9 provides a domain score that ranges from 0- 100 with higher scores representing higher satisfaction on each domain.
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202031 May 2024

First posted4 Feb 2022
Study start15 Jan 2020
Primary completion30 Aug 2023
Study completion31 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CarcinomaStudies of the same condition, open and under way.
More trials run by Columbia 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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05225090
Sponsor's protocol ID: AAAS5950
Status last verified: Sep 2024
First submitted: 11 Mar 2021
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of a Smartphone Application to Improve Medication Adherence Among Patients with Cancer
ClinicalTrials.gov ID: NCT05225090
Acronym / sponsor ID: AAAS5950
Conditions: Carcinoma, Cancer
Keywords: any stage
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: 15 Jan 2020 (actual)
Primary completion: 30 Aug 2023 (actual)
Study completion: 31 May 2024 (actual)
First posted: 4 Feb 2022 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Smartphone App Intervention	Other	Other: Smartphone AppCancer patients taking at least one oral anti-cancer drug or oral medication to manage a chronic condition in conjunction with any cancer treatment will receive messages through the Medisafe App.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Inability to provide informed consent

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
Smartphone AppAlso: Medisafe AppMedisafe is a Med_App that is free and has been used in several studies evaluating medication adherence. Patients will receive individualized instruction and be followed for 12 weeks. The researcher will show the patients how to input current medication list, set up medication reminders and track if daily doses have been taken using the App (20 minute training session). After the participant has input their medication information into the app, the researcher will assist the participant in adding an optional "Medifriend" who will be alerted if the participant misses a dose as an option. The participant will also be provided with written instructions about the Medisafe app to take home for reference. At each office visit (4, 8, and 12 weeks) participants will complete a medication checklist and reconciliation form with the research staff. Participants will also be asked to send a medication status report through the Medisafe app.	Other	Smartphone App Intervention

Primary outcome

Proportion of subjects enrolled that complete the 12-week intervention and assessments
Time frame: 12 weeks
To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients. Feasibility defined as completing the 12-week intervention and the endpoint assessments. Patients will be tallied.

6 secondary outcomes

Change in mean score on the Voils Extent of Adherence Scale for oral caner therapy use between baseline and 12 weeks
Time frame: Baseline and 12 weeks
Change in mean score on the Voils Extent of Adherence Scale for global medication use between baseline and 12 weeks
Time frame: Baseline and 12 weeks
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
Time frame: 12 weeks
Mean Score on the User Version of the Mobile Application Rating Scale
Time frame: 12 weeks
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Score before and after the intervention
Time frame: Baseline and 12 weeks
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Score before and after the intervention
Time frame: Baseline and 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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. This study is not recruiting at the moment.

Melissa Accordino, MD principal investigator

Assistant Professor of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone App in people with Carcinoma and Cancer, run by Columbia 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects enrolled that complete the 12-week intervention and assessments (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05225090.

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 19 Sep 2024.