Care Plans for Cancer Predisposition

NCT05736497 | Completed

• 2 other identifiers: IRB 21-019151R21HG011912
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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).

Conditions

Genetic Predisposition

Keywords

genetic testing; genetic counseling; germline testing; digital care plan; cancer predisposition syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Acceptability of use of digital care plans for CPS for participating family members

  3 months after receipt of digital care plan

• Feasibility of use of digital care plans for CPS for patients diagnosed within 5 years

  Up to 6 months after receipt of digital care plan

• Satisfaction with decision to have germline testing

  Up to 6 months after receipt of digital care plan

• Change in cancer-related anxiety

  Up to 6 months after receipt of digital care plan

• Change in distress after receiving genetic test results

  Up to 6 months after receipt of digital care plan

Study Arms (1)

Intervention: Digital Care Plans with Accompanying Text Messages

EXPERIMENTAL

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

Interventions

Digital Care Plans OTHER

Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 3 years.

Intervention: Digital Care Plans with Accompanying Text Messages

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents
• Parent or Legal Guardian of a patient with a known cancer predisposition syndrome diagnosed within the last 5 years
• 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)
• Appropriate to approach per oncology team/cancer predisposition team
• No cognitive impairment limiting ability to complete measures
• Ability to read and speak English fluently
• Adolescent/Young Adult (AYA) probands
• Child proband with a known cancer predisposition syndrome diagnosed within the last 5 years
• Ages 12+
• 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)
• Appropriate to approach per oncology team/cancer predisposition team
• No cognitive impairment limiting ability to complete measures
• Ability to read and speak English fluently

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne MacFarland, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of pre and post testing of same cohort.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: August 25, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request
• Access Criteria: Upon request

Locations

US (1)