Clinical trial NCT05736497: Care Plans for Cancer Predisposition
Official title: Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Digital Care Plans for Patients With CPS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Predisposition
Keywords: genetic testing
genetic counseling
germline testing
digital care plan
cancer predisposition syndrome
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Human Genome Research Institute (NHGRI)
First posted: 2023-02-21
Enrollment: 164
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Comparison of pre and post testing of same cohort.
Primary purpose: SUPPORTIVE_CARE

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).

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.

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

Primary outcomes:
measure: Change in Knowledge Score of participating family members
timeFrame: 3 months and 6 months after receipt of digital care plan
Secondary outcomes:
measure: Acceptability of use of digital care plans for CPS for participating family members
timeFrame: 3 months after receipt of digital care plan
measure: Feasibility of use of digital care plans for CPS for patients diagnosed within 5 years
timeFrame: Up to 6 months after receipt of digital care plan
measure: Satisfaction with decision to have germline testing
timeFrame: Up to 6 months after receipt of digital care plan
measure: Change in cancer-related anxiety
timeFrame: Up to 6 months after receipt of digital care plan
measure: Change in distress after receiving genetic test results
timeFrame: Up to 6 months after receipt of digital care plan
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Suzanne MacFarland, MD
role: PRINCIPAL_INVESTIGATOR
References: