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NCT Number: NCT07278778

Cancer Care Companion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine/Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Albert Lai, Ph.D.

SUB_INVESTIGATOR

Anna Kerr, Ph.D.

SUB_INVESTIGATOR

Bryan Sisk, MD, MSCI

CONTACT

[email protected]

314-454-6018

Bryan Sisk, MD, MSCI

PRINCIPAL_INVESTIGATOR

Maura Kepper, Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cancer Care Companion

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Information Exchange

    Time frame: Baseline and immediately post-intervention

    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.

  2. Trust in Physicians

    Time frame: Baseline and immediately post-intervention

    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.

  3. Ability to navigate the healthcare system

    Time frame: Baseline and immediately post-intervention

    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.

  4. Caregiver burden

    Time frame: Baseline and immediately post-intervention

    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.

  5. Parental anxiety

    Time frame: Baseline and immediately post-intervention

    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.

  6. Communication Quality

    Time frame: Baseline and immediately post-intervention

    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).

  7. Patient perceptions of tool usability

    Time frame: Immediately post-intervention

    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.

  8. Patient perceptions of tool usefulness

    Time frame: Immediately post-intervention

    The semi-structured interview guide will be developed using the Unified Theory of Acceptance and Use of Technology and theory of Technology Readiness.

  9. Patient perceptions of tool barriers and facilitators

    Time frame: Immediately post-intervention

    The semi-structured interview guide will be developed using the Unified Theory of Acceptance and Use of Technology and theory of Technology Readiness.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan A Sisk, MD, MSCI

CONTACT

[email protected]

314-273-9084

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Study of Cancer Care Companion, An Electronic Health Record Tool to Improve Information Exchange and Self-Management in Pediatric Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Feb 6, 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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