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Clinical Trials/NCT03684005
NCT03684005CompletedNot Applicable

MyPatientPal: An App to Help Patients Manage Their Cancer Care

Felicity Harper2 sites in 1 country40 target enrollmentStarted: October 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Treatment-related symptoms

Study Overview

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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Adherence to medications(Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app)
  • Patient self-efficacy(Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app)

Investigators

Sponsor
Felicity Harper
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Felicity Harper

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Study Sites (2)

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