- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03684005
MyPatientPal: An App to Help Patients Manage Their Cancer Care
March 1, 2021 updated by: Felicity Harper
MyPatientPal was developed in collaboration with both patient and oncologist stakeholders, is designed to facilitate such patient self-management through the daily reporting of side effects and medications.
Study Overview
Detailed Description
MyPatientPal is a patient app that is designed to help patients track and manage treatment side effects and medication adherence on a daily basis.
Side effects (e.g., pain, fatigue, diarrhea, nausea) can be physically and emotionally debilitating, and when uncontrolled, can cause treatment complications, resulting in unscheduled care costs, patient out-of-pocket costs, and delays or discontinuation of treatment.
The app allows personalization of daily entries such that patients can select the specific medications and dosage and side effects (using items from the NCI Common Terminology Criteria for Adverse Events) that they and/or their providers want to track.
A charting feature provides an easy-to-read display of patients' daily reports, summarizing the intensity and frequency of side effects and medication use either by week or by month.
These reports can also be printed out and shared with providers.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a diagnosis of any solid tumor cancer
- Be starting treatment using an oral cancer therapeutic agent
- Be able to speak, read, and write English
- Willing and able to use their smartphone to use MyPatientPal
Exclusion Criteria:
- Patients with cognitive or perceptual disturbances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single-Arm Smartphone App Use
All patients in this single-arm study will use a smartphone-based app, MyPatientPal, to enter symptoms and track medications related to their cancer treatment.
No drugs will be administered for the purposes of this behavioral study.
|
All patients in this single-arm study will use a smartphone-based app, MyPatientPal, to enter symptoms and track medications related to their cancer treatment.
No drugs will be administered for the purposes of this behavioral study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related symptoms
Time Frame: Symptoms will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
|
The frequency of treatment-related symptoms will be examined as the primary outcome.
Patients will report the frequency and severity of symptoms selected from a symptom survey that consists of a list of 17 symptoms derived from the National Cancer Institute (NCI) CTCAE (Common Terminology Criteria for Adverse Events).
Examples include diarrhea, constipation, vomiting, fever, and fatigue.
Patients will be asked to mark the frequency of each symptom using a 5-point rating scale (from 0=none to 4=very severe).
A total symptom impact score will be calculated by summing item responses across all symptoms.
The investigators will compare the overall mean difference between the weekly and daily reporting phases.
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Symptoms will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to medications
Time Frame: Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
|
Patient adherence to oral chemotherapy will be examined as a secondary outcome.
Patients will report any medications they are taking related to their treatment.
Each report will consist of them answering a forced-choice question about whether each of their self-selected medications was taken (0=yes, 1=no).
The investigators will compare the ratio of total days of adherence/total number of days per medication between the weekly and daily reporting phases.
There will be no set number of medications that will be assessed given that patients will self-select their own medications, but on average, patients will report on 3 medications.
Examples may include Xeloda, Ibrance, Femara, Tamoxifen, Remeron, Reglan, or Compazine.
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Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
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Patient self-efficacy
Time Frame: Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
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Patient self-efficacy will be examined as a secondary outcome.
Patient self-efficacy for managing treatment side effects will be assessed with a 13-item version of the Chronic Pain Self-Efficacy Scale, which has been modified for a cancer population.
Items assess patients' self-efficacy for managing and coping with side effects.
Examples are "How certain is the participant that they can control their fatigue?"
and "How certain is the participant that they can cope with mild to moderate pain?" Items are rated on a 10-point Likert scale ranging from 10 = very uncertain and 100 = very certain and items scores are summed for a total score.
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Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Felicity Harper, PhD, Associate Professor/PI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
October 8, 2019
Study Completion (Actual)
October 11, 2019
Study Registration Dates
First Submitted
September 22, 2018
First Submitted That Met QC Criteria
September 22, 2018
First Posted (Actual)
September 25, 2018
Study Record Updates
Last Update Posted (Actual)
March 2, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2018-063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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