Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer
Part of paid clinical trials in Kansas City, Missouri.
- Sponsor
- Virginia Commonwealth University
- Study ID
- NCT05958316
- Status
- Recruiting
Conditions
- Cancer
- Childhood Cancer
- Symptoms and Signs
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 29 Years
- Healthy Volunteers
- Not accepted
Interventions
- Computerized Symptom Capture Tool (C-SCAT) Intervention — BEHAVIORALThe C-SCAT includes the 32 symptoms from the Memorial Symptom Assessment Scale (MSAS). Users select symptoms they have experienced over the past week, rate each symptom's severity and distress, and name a perceived cause. They then identify temporal and causal relationships between symptoms using lines and arrows, designate groups, i.e., "clusters" of symptoms, and give a name to each cluster. They are asked the reason for a symptom's designation as a priority symptom and what they do to alleviate that symptom. Next, they are asked to designate a priority cluster and finally, to confirm whether the image accurately reflects their symptom experience. Then, at the clinic visit, the AYA shares the visual image with the HCP, and more importantly, their priority symptoms, which can facilitate the symptom discussion. The C-SCAT intervention group will complete the C-SCAT prior to each of three encounters with their health care providers (HCPs).
- Usual Care Control — BEHAVIORALUsual care is defined as the usual approach to assessing symptoms during the HCP encounter. To provide attentional control to the usual care control group and prevent disproportionate attrition from that group, study staff will contact participants three times during the intervention period (approximately 3 months) when they are in for a scheduled clinic visit and communicate the following: 1) express appreciation for ongoing study participation; 2) ask how everything is going with their treatment; 3) ask if anything has changed with their treatment plan since the last study visit; and 4) confirm continued participation in the study.
Study Details
Determine the effects of the Computerized Symptom Assessment Tool (C-SCAT) versus usual care on the primary outcomes of self-efficacy for symptom management and symptom self-management behaviors
Key Dates
- Start date
- Jan 4, 2024
- Status verified
- May 2026
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 126 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Computerized Symptom Assessment Tool C-SCATParticipants will be asked to complete the C-SCAT at three of their clinic visits for cancer treatment in addition to usual care for assessing symptoms. This intervention period will last up to about 12 weeks, depending on cancer treatment schedule (for example, every 2, 3 or 4 weeks).
- Active Comparator: Usual Care Control GroupParticipants will follow usual care for cancer symptoms for up to 12 weeks, depending on how cancer treatment schedule (for example, every 2, 3 or 4 weeks).
Primary Outcome Measure
Effects of the C-SCAT versus usual care on the primary outcomes of self-efficacy for symptom management immediately post intervention (Time 1) by comparing the scores from the Patient-Reported Outcomes Measurement Information System®; PROMIS® Scale. [ Time Frame: Baseline- Week 0 ]
Central Contacts
- Grace Hodges804-828-8917
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | Kristin Stegenga (PRINCIPAL_INVESTIGATOR) |
| University of Utah Huntsman Cancer Institute (HCI) | Salt Lake City | Utah | 84112 | Lauri Linder (PRINCIPAL_INVESTIGATOR) |
| University of Utah Primary Children's Hospital | Salt Lake City | Utah | 84113 | Lauri Linder (PRINCIPAL_INVESTIGATOR) |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Ronald Elswick, PhD (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital @ University of Washington | Seattle | Washington | 98105 | - |
Find similar trials in Kansas City, MO
By research site
Related Studies
- Childhood Cancer Survivor StudyRecruiting · St. Jude Children's Research Hospital · Birmingham, Alabama
- SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and RegistryRecruiting · Massive Bio, Inc. · Birmingham, Alabama
- A Crowd Sourcing Platform for Patients With CancerRecruiting · All4Cure · Seattle, Washington
- ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid TumorsPHASE1/PHASE2 · Recruiting · Immatics US, Inc. · Stanford, California