Genetic PredispositionNCT05736497
Care Plans for Cancer Predisposition
A study testing Digital Care Plans in people with Genetic Predisposition, run by Children's Hospital of Philadelphia at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Genetic Predisposition
- What is being tested?
- Digital Care Plans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Not meeting any of inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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).
Read the 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.
- Conditions
- Genetic Predisposition
- Being tested
- Digital Care Plans
- Keywords
- genetic testing, genetic counseling, germline testing, digital care plan, cancer predisposition syndrome
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Care PlansOther
Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 5 years.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital Care Plans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months and 6 months after receipt of digital care plan
Secondary outcomes (4)
Acceptability of Use of Digital Care Plans for CPS
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.
Measured: 3 Months After Receipt of Digital Care Plan
Feasibility of Use of Digital Care Plans for CPS for Patients Diagnosed Within 5 Years
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.
Measured: Up to 6 months after receipt of digital care plan
Satisfaction With Decision (SDS) to Have Germline Testing
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.
Measured: Up to 6 months after receipt of digital care plan
Change in Cancer-Related Anxiety
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.
Measured: Up to 6 months after receipt of digital care plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start25 Aug 2023
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genetic PredispositionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison of pre and post testing of same cohort.
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Suzanne MacFarland, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736497
- Sponsor's protocol ID
- IRB 21-019151
- Other IDs
- R21HG011912
- Status last verified
- Jun 2026
- First submitted
- 8 Feb 2023
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Digital Care Plans for Patients With CPS
- ClinicalTrials.gov ID
- NCT05736497
- Acronym / sponsor ID
- IRB 21-019151
- Conditions
- Genetic Predisposition
- Keywords
- genetic testing, genetic counseling, germline testing, digital care plan, cancer predisposition syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 23 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison of pre and post testing of same cohort.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Digital Care Plans with Accompanying Text Messages | Experimental | Other: Digital Care PlansInvestigators 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting any of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Care PlansInvestigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 5 years. | Other | Intervention: Digital Care Plans with Accompanying Text Messages |
Primary outcome
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.
4 secondary outcomes
Acceptability of Use of Digital Care Plans for CPS
Time frame: 3 Months After Receipt of Digital Care Plan
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
Satisfaction With Decision (SDS) to Have Germline Testing
Time frame: Up to 6 months after receipt of digital care plan
Change in Cancer-Related Anxiety
Time frame: Up to 6 months after receipt of digital care plan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Genetic Predisposition
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome
Familial Cancer, BRCA1-Associated Protein-1 (BAP1) Mutations
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingObservational study
Rare Tumors and Cancer Predisposition in Individuals and Families
Cancer, Hereditary Neoplasms
RecruitingObservational study
Detection and Characterization of Infections and Infection Susceptibility
Immune Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne MacFarland, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Care Plans in people with Genetic Predisposition, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge Score (time frame: 3 months and 6 months after receipt of digital care plan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.