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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA218389 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic educational material | Behavioral | Electronic media via email |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks post-intervention |
| Barriers for Survivor Care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan Marchak, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
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This study and the data presented below only refers to the young adult survivors and does not include parents. Parents were not enrolled in this study. "Participants" refer to young adult cancer survivors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Electronic Educational Material | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Electronic Educational Material | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post-intervention |
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Information on adverse events was collected beginning at the time of the intervention and continuing through the end of the study, at 2 weeks post-intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electronic Educational Material | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jordan Marchak | Emory University | 404-727-2293 | jgillel@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2023 | Mar 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2023 | Jul 9, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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. |
| 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. | 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. | 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. | Baseline, 2 weeks post-intervention |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post-intervention |
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| Secondary | 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. | Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post-intervention |
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| Secondary | 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. | Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post-intervention |
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| Secondary | 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. | Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post-intervention |
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| Secondary | 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. | Total number of participants analyzed per time point include participants that completed the corresponding visit and the specific assessment for this study outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks post-intervention |
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| 0 |
| 89 |
| 2 |
| 89 |
| 0 |
| 89 |
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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