Care Plans for Cancer Predisposition
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention: Digital Care Plans with Accompanying Text Messages 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
Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 3 years.
|
Outcome Measures
Primary Outcome Measures
- Change in Knowledge Score of participating family members [3 months and 6 months after receipt of digital care plan]
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.
Secondary Outcome Measures
- Acceptability of use of digital care plans for CPS for participating family members [3 months after receipt of digital care plan]
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.
- Feasibility of use of digital care plans for CPS for patients diagnosed within 3 years [Up to 6 months after receipt of digital care plan]
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.
- Satisfaction with decision to have germline testing [Up to 6 months after receipt of digital care plan]
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.
- Change in cancer-related anxiety [Up to 6 months after receipt of digital care plan]
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.
- Change in distress after receiving genetic test results [Up to 6 months after receipt of digital care plan]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Parents
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Parent or Legal Guardian of a patient with a known cancer predisposition syndrome diagnosed within the last 3 years
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Receiving routine follow up at the Children's Hospital of Philadelphia (CHOP)
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Appropriate to approach per oncology team/cancer predisposition team
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No cognitive impairment limiting ability to complete measures
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Ability to read and speak English fluently
Adolescent/Young Adult (AYA) probands
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Child proband with a known cancer predisposition syndrome diagnosed within the last 3 years
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Ages 12+
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Receiving routine follow up at CHOP
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Appropriate to approach per oncology team/cancer predisposition team
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No cognitive impairment limiting ability to complete measures
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Ability to read and speak English fluently
Exclusion Criteria:
- Not meeting any of inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
- National Institutes of Health (NIH)
- National Human Genome Research Institute (NHGRI)
Investigators
- Principal Investigator: Suzanne MacFarland, MD, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB 21-019151
- R21HG011912