MyPatientPal: An App to Help Patients Manage Their Cancer Care

Cancer Clinical Trial

Official title:

MyPatientPal: An App to Help Patients Manage Their Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684005
• Other study ID #: 2018-063
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: March 2021
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 11, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Felicity Harper

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related symptoms	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.	Symptoms will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Secondary	Adherence to medications	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.	Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Secondary	Patient self-efficacy	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.	Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app