Pediatric CancerNCT07278778
Cancer Care Companion
A study testing Cancer Care Companion in people with Pediatric Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study invites parents of children with cancer to use an electronic health record (EHR)-based communication tool, called the Cancer Care Companion, and assess the acceptability, appropriateness, and feasibility of the tool. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Cancer Care Companion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria for Parents:
Parents of children with cancer will be enrolled if they meet the following criteria:
- They are a legal guardian of a child diagnosed with cancer in the prior 4 weeks.
- The child plans to receive or currently receives cancer directed therapy at St. Louis Children's Hospital.
- The parent or legal guardian has access to internet through a computer or smart phone.
- Speaks and reads in English
- The parent or legal guardian agrees to enroll in Epic MyChart to access a proxy portal for their child.
Eligibility Criteria for Clinicians:
- Clinicians with patients who have parents participating may be enrolled. Clinician participants will be employed at SLCH or Washington University School of Medicine (WUSM). The clinicians will include physicians, nurse practitioners, and nurse coordinators from the leukemia/lymphoma, brain tumor, and solid tumor teams in order to represent the breadth of pediatric cancer diagnoses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine/Saint Louis Children's Hospital
St Louis, Missouri, 63110
Bryan Sisk, MD, MSCI, 314-454-6018, siskb@wustl.edu
Bryan Sisk, MD, MSCI
About this study
Official title: A Pilot Study of Cancer Care Companion, An Electronic Health Record Tool to Improve Information Exchange and Self-Management in Pediatric Cancer
This study invites parents of children with cancer to use an electronic health record (EHR)-based communication tool, called the Cancer Care Companion, and assess the acceptability, appropriateness, and feasibility of the tool.
Read the detailed description
High-quality communication between clinicians and parents is critical to providing optimal care for pediatric cancer. This study engages parents of children with cancer to use an electronic health record (EHR)-based communication tool, called the Cancer Care Companion, and assess the acceptability, appropriateness, and feasibility of the tool. Parent participants will be given 3 months of access to Cancer Care Companion, after which the participant(s) will complete a semi-structured interview. Participants will also complete a survey of validated measures before and after the intervention.
- Conditions
- Pediatric Cancer
- Being tested
- Cancer Care Companion
- Keywords
- communication, electronic medical record, pediatric cancer
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Care CompanionOther
The investigators will provide parents access the Cancer Care Companion through Epic MyChart. If a participant has not enrolled in MyChart, the investigator will provide instructional materials and assist with registration. Parents will use the Cancer Care Companion for 3 months during which they will complete tasks including educational modules, check-in surveys, and patient stories. Participants may opt-out of receiving the patient stories. During the 3-month intervention, participants will receive 13 educational tasks, 7 check-in surveys, and 5 patient stories (if requested). The Day 1 educational task will include an overview of the program and further instructions. After enrollment, participants will retain access to Cancer Care Companion for at least 3 months, during which they can revisit the content.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All participants receive the Cancer Care Companion program. There is no control or comparison group. Receives: Other: Cancer Care Companion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tool feasibility
The number of tasks marked "complete" divided by total tasks delivered, reported as a percentage per participant, with success defined as meeting or exceeding a 70% completion rate.
Measured: Immediately post-intervention
Secondary outcomes (9)
Information Exchange
Health Literacy of Caregivers Scale-Cancer is a validated tool measuring 10 domains relevant to caregiver health literacy. The information exchange domain includes 4 items with a 4-point Likert response scale assessing whether caregivers have adequate information about cancer and cancer management.
Measured: Baseline and immediately post-intervention
Trust in Physicians
The Trust in Physician Scale is an 11-item tool using a 5-point Likert response scale to assess respondents' perceptions of their doctors' ability to manage (diagnose, treat, make appropriate referrals) their health problem.
Measured: Baseline and immediately post-intervention
Ability to navigate the healthcare system
Health Literacy of Caregivers Scale-Cancer is a validated tool measuring 10 domains relevant to caregiver health literacy. The healthcare system domain includes 6 items with a 4-point Likert response scale assessing whether caregivers understand the healthcare system and how to find care for their child.
Measured: Baseline and immediately post-intervention
Caregiver burden
The short version of the Burden Scale for Family Caregivers is a validated 10-item tool with a 4-point Likert response scale assessing caregiver burden and how it affects the caregivers' physical, mental, and social well-being.
Measured: Baseline and immediately post-intervention
Parental anxiety
The PROMIS Anxiety SF 4a is a validated 4-item tool with a 5-point Likert response scale used to measure emotional distress and anxiety.
Measured: Baseline and immediately post-intervention
Communication Quality
The PedCOM Short Form is a validated 8-item tool using a 5-point Likert response scale that assesses dimensions of communication quality (information exchange, building relationships, making decisions, responding to emotions, supporting hope, providing validation, managing uncertainty, and enabling self-management).
Measured: Baseline and immediately post-intervention
Patient perceptions of tool usability
The System Usability Scale is a validated 10-item tool with a 5-point Likert response scale that measures users perceptions of the complexity, usability, functionality, and value of technological systems.
Measured: Immediately post-intervention
Patient perceptions of tool usefulness
The semi-structured interview guide will be developed using the Unified Theory of Acceptance and Use of Technology and theory of Technology Readiness.
Measured: Immediately post-intervention
Patient perceptions of tool barriers and facilitators
The semi-structured interview guide will be developed using the Unified Theory of Acceptance and Use of Technology and theory of Technology Readiness.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start4 Feb 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bryan A Sisk, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278778
- Sponsor's protocol ID
- 202601022
- Other IDs
- 1R21CA290223-01A1
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be submitted to the Qualitative Data Repository at Syracuse University.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Cancer Care Companion, An Electronic Health Record Tool to Improve Information Exchange and Self-Management in Pediatric Cancer
- ClinicalTrials.gov ID
- NCT07278778
- Acronym / sponsor ID
- 202601022
- Conditions
- Pediatric Cancer
- Keywords
- communication, electronic medical record, pediatric cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study invites parents of children with cancer to use an electronic health record (EHR)-based communication tool, called the Cancer Care Companion, and assess the acceptability, appropriateness, and feasibility of the tool.
Detailed description
High-quality communication between clinicians and parents is critical to providing optimal care for pediatric cancer. This study engages parents of children with cancer to use an electronic health record (EHR)-based communication tool, called the Cancer Care Companion, and assess the acceptability, appropriateness, and feasibility of the tool. Parent participants will be given 3 months of access to Cancer Care Companion, after which the participant(s) will complete a semi-structured interview. Participants will also complete a survey of validated measures before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Other: Cancer Care CompanionAll participants receive the Cancer Care Companion program. There is no control or comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Cancer Care CompanionThe investigators will provide parents access the Cancer Care Companion through Epic MyChart. If a participant has not enrolled in MyChart, the investigator will provide instructional materials and assist with registration. Parents will use the Cancer Care Companion for 3 months during which they will complete tasks including educational modules, check-in surveys, and patient stories. Participants may opt-out of receiving the patient stories. During the 3-month intervention, participants will receive 13 educational tasks, 7 check-in surveys, and 5 patient stories (if requested). The Day 1 educational task will include an overview of the program and further instructions. After enrollment, participants will retain access to Cancer Care Companion for at least 3 months, during which they can revisit the content. | Other | All Participants |
Primary outcome
Tool feasibility
Time frame: Immediately post-intervention
The number of tasks marked "complete" divided by total tasks delivered, reported as a percentage per participant, with success defined as meeting or exceeding a 70% completion rate.
9 secondary outcomes
Information Exchange
Time frame: Baseline and immediately post-intervention
Trust in Physicians
Time frame: Baseline and immediately post-intervention
Ability to navigate the healthcare system
Time frame: Baseline and immediately post-intervention
Caregiver burden
Time frame: Baseline and immediately post-intervention
Parental anxiety
Time frame: Baseline and immediately post-intervention
Communication Quality
Time frame: Baseline and immediately post-intervention
Patient perceptions of tool usability
Time frame: Immediately post-intervention
Patient perceptions of tool usefulness
Time frame: Immediately post-intervention
Patient perceptions of tool barriers and facilitators
Time frame: Immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be submitted to the Qualitative Data Repository at Syracuse University.
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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.
Bryan A Sisk, MD, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Care Companion in people with Pediatric Cancer, run by Washington University School of Medicine 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?
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: looking for participants now, as of the sponsor's last update on 6 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan A Sisk, MD, MSCI (314-273-9084, siskb@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tool feasibility (time frame: Immediately post-intervention). 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 6 Feb 2026.