Care Plans for Cancer Predisposition

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Digital Care Plans for Patients With CPS

Conditions
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Genetic Predisposition

Intervention / Treatment
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* Other: Digital Care Plans


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents Parent or Legal Guardian of a patient with a known cancer predisposition syndrome diagnosed within the last 5 years Received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP) Appropriate to approach per oncology team/cancer predisposition team No cognitive impairment limiting ability to complete measures Ability to read and speak English fluently Adolescent/Young Adult (AYA) probands Child proband with a known cancer predisposition syndrome diagnosed within the last 5 years Ages 12+ Received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP) Appropriate to approach per oncology team/cancer predisposition team No cognitive impairment limiting ability to complete measures Ability to read and speak English fluently Exclusion Criteria: Not meeting any of inclusion criteria

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Comparison of pre and post testing of same cohort.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Digital Care Plans with Accompanying Text Messages<br>Investigators will recruit families and patients diagnosed with a Cancer Predisposition Syndrome within 3 years. Participants will be provided with a digital care plan and optional accompanying text message reminders. | Other: Digital Care Plans<br>* Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 3 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 indicates higher satisfaction, perceived appropriateness, positive effect, demand, and potential for future use. | 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 | 
| Change in distress after receiving genetic test results | Distress after receipt of genetic test results 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 distress about genetic test result disclosure. | Up to 6 months after receipt of digital care plan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic testing, genetic counseling, germline testing, digital care plan, cancer predisposition syndrome