NCT04484194

Brief Summary

The purpose of this study is to modify an existing Seattle Children's Hospital investigator-developed, patient-centered, electronic health assessment (eHA) called "Check Yourself" for AYAs with cancer. The investigators will then evaluate the new eHA prototype for feasibility and acceptability among AYAs with cancer and their oncology providers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Typical duration for phase_1

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

July 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

July 14, 2020

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Determine the feasibility of eHA tool in AYA patients undergoing cancer directed therapy.

    Determine the feasibility of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the feasibility of intervention measure (FIM) tool survey.

    12 months

  • Determine the acceptability of eHA tool in AYA patients undergoing cancer directed therapy.

    Determine the acceptability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the acceptability of intervention measure (AIM) tool survey.

    12 months

  • Determine the usability of eHA tool in AYA patients undergoing cancer directed therapy.

    Determine the usability of Electronic Health Assessment (eHA) tool in AYA population with cancer diagnosis using the usability of intervention of appropriateness measure (IAM) tool survey.

    12 months

Study Arms (1)

eHA Screening

EXPERIMENTAL

Patients receiving eHA screening tool.

Behavioral: Check Yourself - Oncology

Interventions

A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.

Also known as: Electronic Health Assessment (eHA)
eHA Screening

Eligibility Criteria

Age13 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eligible adolescents and young adults will be 13 to 29 years old, have an oncologic diagnosis for which they are receiving cancer directed therapy, have an appointment to see an SCH oncology provider and will be able to understand English.
  • Eligible oncology providers will either be a Physician (Fellow or Attending) or Advance Practice Provider (Nurse Practitioner or Physicians Assistant), have an appointment to see an adolescent or young adult receiving cancer directed therapy receiving who is also enrolled on the study.

You may not qualify if:

  • Participants will be excluded from the study if they do not meet age requirements, do not have an appointment in oncology clinic, lack the means to complete follow-up interviews (i.e., has neither telephone nor internet access), and/or are not able to understand English. Our experience in the Seattle region is that, because of English Language Learning schooling supports, inability to read or understand English is a barrier for \<0.5% of adolescents. Thus, we do not anticipate that language restrictions will significantly limit the demographic distribution of our participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tyler G Ketterl, MD, MS

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Single center pilot feasibility study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Pediatrics

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 23, 2020

Study Start

April 15, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations