Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MyPatientPal: An App to Help Patients Manage Their Cancer Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684005
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Felicity Harper, Barbara Ann Karmanos Cancer Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Other: MyPatientPal smartphone app Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MyPatientPal: An App to Help Patients Manage Their Cancer Care
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : October 8, 2019
Actual Study Completion Date : October 11, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Other: MyPatientPal smartphone app
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684005


Locations
Layout table for location information
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Felicity Harper
Investigators
Layout table for investigator information
Principal Investigator: Felicity Harper, PhD Associate Professor/PI
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Felicity Harper, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT03684005    
Other Study ID Numbers: 2018-063
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No