Care Plans for Cancer Predisposition

NCT05736497 | Completed Results

• 2 other identifiers: IRB 21-019151R21HG011912
• Study Type: interventional
• Target: 177
• 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

  The primary outcome is the percentage of correct items on a knowledge survey that was developed for this study and administered via REDCap, measured at baseline (2 weeks prior to receiving the Care Plan/text message intervention), midpoint (3 months post receiving the Care Plan/text message intervention), and final (6 months post receiving the Care Plan/text message intervention) surveys. The change in the mean and standard deviation will be assessed at 3 months and 6 months. Participants evaluated included the caregivers and AYAs aged 12-26. Total scores were generated by summarizing total number of correct responses and generating a percentage. The knowledge measure included a mix of 10-12 multiple choice and true/false questions, CPS dependent. Higher scores indicate higher CPS knowledge and Care Plan content.

  3 months and 6 months after receipt of digital care plan

Secondary Outcomes (4)

• Acceptability of Use of Digital Care Plans for CPS

  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 (SDS) 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

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 5 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 5 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

Results Point of Contact

• Title: Suzanne MacFarland, MD
• Organization: Children's Hospital of Philadelphia

macfarlands@chop.edu

2153006428

Study Officials

• Suzanne MacFarland, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 23, 2026
• Results First Posted: July 23, 2026

Record last verified: 2026-06

Data Sharing

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

Locations

US (1)