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Care Plans for Cancer Predisposition

Primary Purpose

Genetic Predisposition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Care Plans
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Genetic Predisposition focused on measuring genetic testing, genetic counseling, germline testing, digital care plan, cancer predisposition syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention: Digital Care Plans with Accompanying Text Messages

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 indicates higher satisfaction, perceived appropriateness, positive effect, demand, and potential for future use.
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.
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.
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.
Change in distress after receiving genetic test results
Distress after receipt of genetic test results 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 distress about genetic test result disclosure.

Full Information

First Posted
February 8, 2023
Last Updated
October 10, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI)
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1. Study Identification

Unique Protocol Identification Number
NCT05736497
Brief Title
Care Plans for Cancer Predisposition
Official Title
Integration of Multimodal Cancer Predisposition Genetic Counseling Practices Within the Pediatric Oncology Setting: Digital Care Plans for Patients With CPS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institutes of Health (NIH), National Human Genome Research Institute (NHGRI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Predisposition
Keywords
genetic testing, genetic counseling, germline testing, digital care plan, cancer predisposition syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Comparison of pre and post testing of same cohort.
Masking
None (Open Label)
Allocation
N/A
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Digital Care Plans with Accompanying Text Messages
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Digital Care Plans
Intervention Description
Investigators will develop digital care plans for 10 common Cancer Predisposition Syndromes for patients diagnosed within 3 years.
Primary Outcome Measure Information:
Title
Change in Knowledge Score of participating family members
Description
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.
Time Frame
3 months and 6 months after receipt of digital care plan
Secondary Outcome Measure Information:
Title
Acceptability of use of digital care plans for CPS for participating family members
Description
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 indicates higher satisfaction, perceived appropriateness, positive effect, demand, and potential for future use.
Time Frame
3 months after receipt of digital care plan
Title
Feasibility of use of digital care plans for CPS for patients diagnosed within 5 years
Description
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.
Time Frame
Up to 6 months after receipt of digital care plan
Title
Satisfaction with decision to have germline testing
Description
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.
Time Frame
Up to 6 months after receipt of digital care plan
Title
Change in cancer-related anxiety
Description
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.
Time Frame
Up to 6 months after receipt of digital care plan
Title
Change in distress after receiving genetic test results
Description
Distress after receipt of genetic test results 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 distress about genetic test result disclosure.
Time Frame
Up to 6 months after receipt of digital care plan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne MacFarland, MD
Phone
(267) 425-1919
Email
macfarlands@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Schwartz, PhD
Phone
267-426-0355
Email
schwartzl@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne MacFarland, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne MacFarland, MD
Phone
267-425-1919
Email
macfarlands@chop.edu
First Name & Middle Initial & Last Name & Degree
Lisa Schwartz, PhD
Phone
267-426-0355
Email
schwartzl@chop.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Care Plans for Cancer Predisposition

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