CancerNCT04257058
Education Tools to Support Pediatric Survivor Care
A study testing Electronic educational material in people with Cancer and Pediatric Cancer, run by Emory University at 1 site in United States.
Trial summary
This study aims to evaluate the impact of electronic educational materials on adolescent and young adult (AYA) survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Pediatric Cancer
- What is being tested?
- Electronic educational material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 13 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must be 18-25 years of age,
- Diagnosed with cancer at ≤ 18 years of age,
- ≥ 2 years since the last cancer treatment,
- seen at least once in the Aflac Cancer Survivor Program (CSP) in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013.
Who cannot join
- Patients will be excluded from participation in the study if the participant is non-English speaking.
- Young adult survivors who are cognitively impaired and unable to complete the questionnaires.
- Participants that do not consent to the recording of their interviews.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Predicting Childhood Cancer Survivors' Transition Readiness & Transfer Outcomes (SURV Transfer Outcomes) (Administrative Supplement to R01CA218389)
This study aims to evaluate the impact of electronic educational materials on adolescent and young adult (AYA) survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.
Read the detailed description
Despite increased risk for morbidity and mortality related to cancer treatment, over half of young adult survivors of childhood cancer do not engage in the recommended healthcare designed to detect late effects and secondary cancers. There is a scarcity of data on adherence to survivor-focused healthcare, particularly at the critical transition from pediatrics to adult care. In order to improve transition outcomes, the investigators need to create media to educate survivors about need for adherence to adult survivor healthcare.
This study aims to evaluate the impact of electronic educational materials on AYA survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.
- Conditions
- Cancer, Pediatric Cancer
- Being tested
- Electronic educational material
- Keywords
- Behavioral study, Social study, Pediatric cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic educational materialBehavioural
Electronic media via email
| Study group | Role | What they receive |
|---|---|---|
| Electronic educational material | Experimental | Participants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed. Receives: Behavioral: Electronic educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivor Care Knowledge Scale
Knowledge was assessed at baseline and 2 weeks post-intervention, with the Survivor Care Knowledge scale, that includes 15-item multiple-choice quiz to assess participants' knowledge of the content covered in the electronic educational materials previously provided. Total score ranges from 0-15. Higher score is associated with better outcome.
Measured: Baseline, 2 weeks post-intervention
Secondary outcomes (5)
Benefits for Survivor Care
5-item study adapted Champion Benefits Scale for Mammography Screening. Total score ranges from 5-25. Lower score equals fewer perceived benefits of survivor care.
Measured: Baseline, 2 weeks post-intervention
Barriers for Survivor Care
11-item study adapted Champion Barriers Scale for Mammography Screening. Total score ranges from 11-55. Lower score equals fewer perceived barriers to survivor care.
Measured: Baseline, 2 weeks post-intervention
Perceived Susceptibility for Late Effects
3-item study adapted Champion Susceptibility Scale for Mammography Screening. Total score ranges from 3-15. Lower score equals less susceptibility to late effects of treatment.
Measured: Baseline, 2 weeks post-intervention
Intentions for Survivor Care
2-item study adapted Ajzen's Theory of Planned Behavior- Intentions. Total score ranges from 2-14. Lower score equals greater intention to engage in long-term follow-up care.
Measured: Baseline, 2 weeks post-intervention
Change in Perceived Health Competence Scale (PHCS)
8-item Perceived Health Competence Scale (PHCS). Total score ranges from 8-40. Lower score equals lower perceived health competence.
Measured: Baseline, 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Jun 2022
- Primary completion13 Apr 2024
- Study completion13 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jordan Marchak, Emory University
- Investigators
- Jordan Marchak, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257058
- Sponsor's protocol ID
- IRB00091839
- Other IDs
- R01CA218389
- Status last verified
- May 2025
- First submitted
- 4 Feb 2020
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Childhood Cancer Survivors' Transition Readiness & Transfer Outcomes (SURV Transfer Outcomes) (Administrative Supplement to R01CA218389)
- ClinicalTrials.gov ID
- NCT04257058
- Acronym / sponsor ID
- IRB00091839
- Conditions
- Cancer, Pediatric Cancer
- Keywords
- Behavioral study, Social study, Pediatric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the impact of electronic educational materials on adolescent and young adult (AYA) survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.
Detailed description
Despite increased risk for morbidity and mortality related to cancer treatment, over half of young adult survivors of childhood cancer do not engage in the recommended healthcare designed to detect late effects and secondary cancers. There is a scarcity of data on adherence to survivor-focused healthcare, particularly at the critical transition from pediatrics to adult care. In order to improve transition outcomes, the investigators need to create media to educate survivors about need for adherence to adult survivor healthcare.
This study aims to evaluate the impact of electronic educational materials on AYA survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic educational material | Experimental | Behavioral: Electronic educational materialParticipants in the trial included young adult survivors of childhood cancer. Participants completed an online pre-test survey via REDCap. After the pre-test is completed, participants review electronic media in REDCap. Study staff confirmed review of material and scheduled a post-test survey to be competed in REDCap two weeks after material is reviewed. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients must be 18-25 years of age,
- Diagnosed with cancer at ≤ 18 years of age,
- ≥ 2 years since the last cancer treatment,
- seen at least once in the Aflac Cancer Survivor Program (CSP) in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013.
Key exclusion criteria (3 listed)
- Patients will be excluded from participation in the study if the participant is non-English speaking.
- Young adult survivors who are cognitively impaired and unable to complete the questionnaires.
- Participants that do not consent to the recording of their interviews.
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 |
|---|---|---|
| Electronic educational materialElectronic media via email | Behavioural | Electronic educational material |
Primary outcome
Survivor Care Knowledge Scale
Time frame: Baseline, 2 weeks post-intervention
Knowledge was assessed at baseline and 2 weeks post-intervention, with the Survivor Care Knowledge scale, that includes 15-item multiple-choice quiz to assess participants' knowledge of the content covered in the electronic educational materials previously provided. Total score ranges from 0-15. Higher score is associated with better outcome.
5 secondary outcomes
Benefits for Survivor Care
Time frame: Baseline, 2 weeks post-intervention
Barriers for Survivor Care
Time frame: Baseline, 2 weeks post-intervention
Perceived Susceptibility for Late Effects
Time frame: Baseline, 2 weeks post-intervention
Intentions for Survivor Care
Time frame: Baseline, 2 weeks post-intervention
Change in Perceived Health Competence Scale (PHCS)
Time frame: Baseline, 2 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jordan Marchak, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic educational material in people with Cancer and Pediatric Cancer, run by Emory University 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 4 inclusion and 3 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 15 May 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survivor Care Knowledge Scale (time frame: Baseline, 2 weeks post-intervention). 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 15 May 2025.