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Completed

NCT Number: NCT05736497

Care Plans for Cancer Predisposition

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).

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Key information

Conditions

Genetic Predisposition Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not meeting any of inclusion criteria

Treatment and study plan

Digital Care Plans

Other

Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 5 years.

Primary outcomes

  1. Change in Knowledge Score

    Time frame: 3 months and 6 months after receipt of digital care plan

    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.

Secondary outcomes

  1. Acceptability of Use of Digital Care Plans for CPS

    Time frame: 3 Months After Receipt of Digital Care Plan

    Acceptability: a 3-question acceptability measure created for this project, scored on a Likert scale from 1=Not at All to 5=Completely. Higher total scores indicate greater acceptability on ease of understanding the Care Plan, new information gained from the Care Plan, and its general usefulness. Scores range from 0-15, with higher scores indicating greater acceptability of the Care Plan.

  2. Feasibility of Use of Digital Care Plans for CPS for Patients Diagnosed Within 5 Years

    Time frame: Up to 6 months after receipt of digital care plan

    Feasibility will be assessed with absence of mean number of technical difficulties of Care Plan Creation by the Clinical Research Coordinator (CRC) in under 15 minutes in a busy clinical setting. The CRC made note of any technical difficulties at creation of Care Plan via REDCap.

  3. Satisfaction With Decision (SDS) to Have Germline Testing

    Time frame: Up to 6 months after receipt of digital care plan

    Satisfaction with decision to have germline testing will be measured by participants' completion of electronic questionnaires administered via REDCap. Satisfaction with Decision Scale (SDS): a 6-question decision satisfaction measure, scored on a Likert scale from 1= Strongly Disagree to 5= Strongly Agree. Higher total scores indicate greater satisfaction with decisions for pursuing genetic testing. Scores range from 0-30, with higher scores indicating greater satisfaction.

  4. Change in Cancer-Related Anxiety

    Time frame: Up to 6 months after receipt of digital care plan

    This 15-item measure assesses cancer-related anxiety through two subscales (intrusive thinking and avoidance). Responses are measured on a 4-point Likert scale with the following anchors: 0 "not at all", 1 "rarely", 3 "sometimes", and 5 "often". Scores range from 0 to 35 for intrusion, 0 to 40 for avoidance, and 0 to 75 for the total IES. Higher scores indicate greater cancer-related anxiety. Cancer-related anxiety will be measured by participants' completion of electronic questionnaires administered via REDCap.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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