- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07928154
MyPatientPal+: A Smartphone App and a Provider Dashboard to Manage Patient Care While on Treatment
The overall goal of this clinical trial is to assess the feasibility of implementing MyPatientPal+ a smartphone app and provider dashboard, to collect daily patient-reported outcome data from patients and share with providers to improve the effective management of treatment-related side effects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study focuses on testing the effectiveness of MyPatientPal+, the combination of MyPatientPal smartphone app and a newly developed provider dashboard, on patient quality of life, adherence to medications, and severity of side effects on patients who are on cancer treatment. Participants will use the MyPatientPal+ smartphone daily to complete daily patient reported outcome questions (PROs) for 8 weeks. Providers will enter information as desired and not on a set schedule.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lead Clinical Research Associate
- Phone Number: +1 313-576-9735
- Email: phalorej@karmanos.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
-
Contact:
- Lead Clinical Research Associate
- Phone Number: +1 313-576-9735
- Email: phalorej@karmanos.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients-
- 18-70 Years of age
- have a diagnosis of breast, any gastrointestinal, lung, prostate, head and neck, or bladder cancer
- about to initiate chemotherapy using one of the regimens listed in the protocol
- be able to speak, read, and write English
- willing and able to provide consent
- have access to a stable internet connection
Providers:
- being a practicing oncologist
- treating patients at Karmanos Cancer Institute (KCI) who are enrolled and consent to using the MyPatientPal+ smartphone app
- provide consent for the study
Exclusion Criteria:
Patients-
- cognitive or perceptual disturbances that prevent completing study measures Provider-
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MyPatientPal+ Smartphone Application
Participants report daily side effects and medications. Application includes a provider dashboard to track patients side effects and medications. |
The intervention will consist of patients using the MyPatientPal+ application to complete daily patient reported outcome questions (PROs) of: (a) patient quality of life, (b) medication use, and (c) severity of side effects, and their providers who will elect to receive a weekly summary of patient's daily PRO reports electronically (e.g., email) or through the dashboard. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single-item daily Quality of Life (Patient)
Time Frame: Daily for 8 weeks
|
Patients will report their daily quality of life daily using MyPatientPal smartphone app. The question: "How was your quality of life today?" has a 7-point scale ranging from 1=very poor to 7=excellent. |
Daily for 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to medications (patient)
Time Frame: Daily for 8 weeks
|
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 prescribed 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 the app will be set up to record only those medications the patient is prescribed, but on average, most patients will report on 3 medications. Examples may include Xeloda, Ibrance, Femara, Tamoxifen, Remeron, Reglan, or Compazine. |
Daily for 8 weeks
|
|
Severity of side effects (patient)
Time Frame: Daily for 8 weeks
|
The severity of treatment-related symptoms will be examined as the primary outcome. Patients will report the severity of symptoms selected to match their current or expected side using 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 severity of each symptom using a 5-point rating scale (from 0=none to 4=very severe). |
Daily for 8 weeks
|
|
Patient quality of life
Time Frame: Weekly for 8 weeks
|
Patients will report their quality of life using the FACT-G (Functional Assessment of Cancer Therapy), a widely accepted measure of general functioning and quality of life among cancer patients. The measure has a total score and also four subscales assessing social, functional, emotional, and physical domains. |
Weekly for 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Felicity Harper, Ph.D., Barbara Ann Karmanos Cancer Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Respiratory Tract Diseases
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Skin Diseases
- Breast Diseases
- Urologic Neoplasms
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Prostatic Neoplasms
- Lung Neoplasms
- Breast Neoplasms
- Disease
- Gastrointestinal Neoplasms
- Head and Neck Neoplasms
- Urinary Bladder Neoplasms
Other Study ID Numbers
- 2025-091
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.