Risk Reduction BehaviorPhase 1AHEADNCT04484194
Assessing Health Electronically for Adolescent and Young Adult Oncology
A Phase 1 study testing Check Yourself - Oncology in people with Risk Reduction Behavior, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 29 years
- Conditions the study is for
- Risk Reduction Behavior
- What is being tested?
- Check Yourself - Oncology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 31 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Health Electronically for Adolescent and Young Adult Oncology (AHEAD)
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.
Read the 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.
- Conditions
- Risk Reduction Behavior
- Being tested
- Check Yourself - Oncology
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Check Yourself - OncologyBehavioural
Also called Electronic Health Assessment (eHA)
A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.
| Study group | Role | What they receive |
|---|---|---|
| eHA Screening | Experimental | Patients receiving eHA screening tool. Receives: Behavioral: Check Yourself - Oncology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center pilot feasibility study.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tickit Health Solutions
- Responsible party
- Principal investigator, Tyler Ketterl, MD, MS, Seattle Children's Hospital
- Investigators
- Tyler G Ketterl, MD, MS, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484194
- Sponsor's protocol ID
- STUDY00002661
- Acronym
- AHEAD
- Status last verified
- Apr 2023
- First submitted
- 14 Jul 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Health Electronically for Adolescent and Young Adult Oncology (AHEAD)
- ClinicalTrials.gov ID
- NCT04484194
- Acronym / sponsor ID
- AHEAD / STUDY00002661
- Conditions
- Risk Reduction Behavior
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Tickit Health Solutions
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center pilot feasibility study.
| Arm | Type | Receives |
|---|---|---|
| eHA Screening | Experimental | Behavioral: Check Yourself - OncologyPatients receiving eHA screening tool. |
Who may qualify
- Ages
- 13 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Check Yourself - OncologyAlso: Electronic Health Assessment (eHA)A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics. | Behavioural | eHA Screening |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler G Ketterl, MD, MS principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Check Yourself - Oncology in people with Risk Reduction Behavior, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of eHA tool in AYA patients undergoing cancer directed therapy. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.