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Trial Title:
Care Plans for Cancer Predisposition
NCT ID:
NCT05736497
Condition:
Genetic Predisposition
Conditions: Official terms:
Disease Susceptibility
Genetic Predisposition to Disease
Conditions: Keywords:
genetic testing
genetic counseling
germline testing
digital care plan
cancer predisposition syndrome
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Comparison of pre and post testing of same cohort.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Digital Care Plans
Description:
Investigators will develop digital care plans for 10 common Cancer Predisposition
Syndromes for patients diagnosed within 3 years.
Arm group label:
Intervention: Digital Care Plans with Accompanying Text Messages
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).
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Parents
1. Parent or Legal Guardian of a patient with a known cancer predisposition syndrome
diagnosed within the last 5 years
2. 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)
3. Appropriate to approach per oncology team/cancer predisposition team
4. No cognitive impairment limiting ability to complete measures
5. Ability to read and speak English fluently
Adolescent/Young Adult (AYA) probands
1. Child proband with a known cancer predisposition syndrome diagnosed within the last
5 years
2. Ages 12+
3. 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)
4. Appropriate to approach per oncology team/cancer predisposition team
5. No cognitive impairment limiting ability to complete measures
6. Ability to read and speak English fluently
Exclusion Criteria:
- Not meeting any of inclusion criteria
Gender:
All
Minimum age:
12 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Start date:
August 25, 2023
Completion date:
April 2025
Lead sponsor:
Agency:
Children's Hospital of Philadelphia
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Human Genome Research Institute (NHGRI)
Agency class:
NIH
Source:
Children's Hospital of Philadelphia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05736497
