- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484194
Assessing Health Electronically for Adolescent and Young Adult Oncology (AHEAD)
Assessing Health Electronically for Adolescent and Young Adult Oncology (AHEAD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Unmet needs among Adolescents and Young Adults (AYAs) with cancer translate to poor physical and psychosocial outcomes. This is particularly true when it comes to AYA sexual health. Our team has found that intimate relationships and risky health behaviors are common among AYAs during their cancer experience, that oncology clinicians rarely ask about these behaviors, and that AYAs rarely volunteer to share these behaviors. As a result, AYAs with cancer are deprived of the surveillance, anticipatory guidance, and normative support participants would have received if participants were well. Currently there is no standard screening process for risk behaviors and the recommended psychosocial screening for AYAs in the SCH oncology clinic setting. To address this problem, the investigators propose to adapt a validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.
The purpose of this study is to modify an existing Seattle Children's Hospital investigator-developed, patient-centered, electronic health assessment (eHA) 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.
AIM 1. To evaluate the modified eHA program prototype for feasibility, acceptability, and process measures. The investigators will enroll a cohort of N=25 AYAs with cancer and N=10 providers from our institution to "beta-test" the program.
Hypothesis 1: There will be applicable and nonapplicable eHA content for AYAs with cancer in the current electronic health assessment (eHA) tool in addition to content relative to AYAs with cancer that should be developed and added.
Hypothesis 2: AYAs will report that the modified AYA oncology specific eHA is both useful and easy to use. Additionally, oncology providers will report that the eHA tool was useful and positively impacted patient care.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98105
- Seattle Children's
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eHA Screening
Patients receiving eHA screening tool.
|
A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the feasibility of eHA tool in AYA patients undergoing cancer directed therapy.
Time Frame: 12 months
|
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.
Time Frame: 12 months
|
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.
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tyler G Ketterl, MD, MS, Seattle Children's Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00002661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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