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| ID | Type | Description | Link |
|---|---|---|---|
| R21HG011912 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Human Genome Research Institute (NHGRI) | NIH |
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Develop and evaluate acceptability, feasibility, and preliminary efficacy of digital care plan and accompanying text message reminders for children and adolescents with a known Cancer Predisposition Syndromes (CPS).
As over 15% of pediatric cancers are associated with a cancer predisposition, it is increasingly becoming standard of care for children with cancer, as well as those with suspected hereditary risk, to be evaluated for germline cancer predisposition. Unfortunately, the increase in pediatric genetic testing has exceeded the pace of research supporting effective cancer surveillance in positive cases. Additionally, guidelines for cancer predisposition management are not easily accessed or understood by families; thus, there is often a disconnect between the understanding and retention of such information relayed to families.
In this study, Investigators will develop and evaluate the acceptability, feasibility, and preliminary efficacy of digital care plans for Cancer Predisposition Syndromes (CPS) with accompanying text message reminders for children and adolescents with a known CPS. Digital care plans and text messages will be created for 10 common CPS. Investigators will use a quasi-experimental design with pre and post testing of the same cohort, before and after delivery of care plan and accompanying messages. To evaluate the impact of the digital care plans, Investigators will compare assessments of the same cohorts at 3 and 6 months time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Digital Care Plans with Accompanying Text Messages | Experimental | Investigators will recruit families and patients diagnosed with a Cancer Predisposition Syndrome within 5 years. Participants will be provided with a digital care plan and optional accompanying text message reminders. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Care Plans | Other | Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 5 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Knowledge Score of participating family members | Change in knowledge score for participating family members will be measured by participants completion of electronic questionnaires administered via REDCap. The change in the mean and standard deviation will be assessed at 3 months and 6 months. A higher score indicates greater knowledge of care plans content. | 3 months and 6 months after receipt of digital care plan |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of use of digital care plans for CPS for participating family members | Acceptability will be measured by participants' completion of electronic questionnaires administered via REDCap. Acceptability ratings will be documented with standard descriptive statistics such as means and frequencies. A higher score indicates higher satisfaction, perceived appropriateness, perceived positive effect, and potential for future use. |
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Inclusion Criteria:
Parents
Adolescent/Young Adult (AYA) probands
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne MacFarland, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Investigators are committed to making all data, protocols, tools, and materials available to the scientific community, in compliance with Children's Hospital of Philadelphia policies and NIH "Sharing Data and Resources" statement, NIH Grants Policy Statement, and the NIH Office of Extramural Research, Division of Extramural Inventions & Technology Resources (DEITR) Intellectual Property Policy. This includes sharing of protocols freely with collaborators and sharing of data through peer-reviewed publication and presentation in scientific meetings. All members of the research team will comply with the NIH policy on sharing data by protecting the privacy and rights of human subjects involved in the research at all times. All members of the research team with comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its accompanying regulations.
Upon request
Upon request
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 3, 2026 | |
| Reset | Jun 26, 2026 |
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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 | Jun 18, 2024 | Dec 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Written Consent Form | Jun 6, 2024 | Dec 16, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Verbal Consent Form | Jun 6, 2024 | Dec 16, 2025 | ICF_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2026 | Jun 26, 2026 | |||
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Comparison of pre and post testing of same cohort.
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| 3 months after receipt of digital care plan |
| Feasibility of use of digital care plans for CPS for patients diagnosed within 5 years | Feasibility will be assessed with absence of technical difficulties allowing the Clinical Research Coordinator (CRC) to create care plan in under 15 minutes in a busy clinical setting. | Up to 6 months after receipt of digital care plan |
| Satisfaction with decision to have germline testing | Satisfaction with decision to have germline testing will be measured by participants' completion of electronic questionnaires administered via REDCap. The change in the mean and standard deviation will be assessed at 3 months and 6 months and compared to baseline. A higher score indicates greater satisfaction with decision to have child genetically tested. | Up to 6 months after receipt of digital care plan |
| Change in cancer-related anxiety | Cancer-related anxiety will be measured by participants' completion of electronic questionnaires administered via REDCap. The change in the mean and standard deviation will be assessed at 3 months and 6 months and compared to baseline. A higher score indicates greater cancer-related stress. | Up to 6 months after receipt of digital care plan |