Care Plans for Cancer Predisposition

Genetic Predisposition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736497
• Other study ID #: IRB 21-019151
• Secondary ID: R21HG011912
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Children's Hospital of Philadelphia
• Contact: Suzanne MacFarland, MD
• Phone: (267) 425-1919
• Email: macfarlands[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Other:
• Digital Care Plans
Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 3 years.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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