Care Plans for Cancer Predisposition

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

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).

Study Overview

• Status: Completed
• Conditions: Genetic Predisposition
• Intervention / Treatment: Other: Digital Care Plans

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 Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 5 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 5 years.

What is the study measuring?

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
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
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 higher satisfaction, perceived appropriateness, perceived positive effect, and potential for future use.	3 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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institutes of Health (NIH); National Human Genome Research Institute (NHGRI)
• Investigators: Principal Investigator: Suzanne MacFarland, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): June 10, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: genetic testing; genetic counseling; germline testing; digital care plan; cancer predisposition syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Pathological Conditions, Signs and Symptoms; Genetic Predisposition to Disease
• Other Study ID Numbers: IRB 21-019151; R21HG011912 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators are committed to making all data, protocols, tools, and materials available to the scientific community, in compliance with Children's Hospital of Philadelphia policies and NIH "Sharing Data and Resources" statement, NIH Grants Policy Statement, and the NIH Office of Extramural Research, Division of Extramural Inventions & Technology Resources (DEITR) Intellectual Property Policy. This includes sharing of protocols freely with collaborators and sharing of data through peer-reviewed publication and presentation in scientific meetings. All members of the research team will comply with the NIH policy on sharing data by protecting the privacy and rights of human subjects involved in the research at all times. All members of the research team with comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its accompanying regulations.
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No