NCT03684005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2019

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

September 22, 2018

Last Update Submit

March 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Single-Arm Smartphone App Use

OTHER

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

Interventions

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.

Single-Arm Smartphone App Use

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with cognitive or perceptual disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Felicity Harper, PhD

    Associate Professor/PI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2018

First Posted

September 25, 2018

Study Start

October 1, 2018

Primary Completion

October 8, 2019

Study Completion

October 11, 2019

Last Updated

March 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations