Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer
NCT ID: NCT05958316
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2024-01-04
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Computerized Symptom Assessment Tool C-SCAT
Participants 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).
Computerized Symptom Capture Tool (C-SCAT) Intervention
The 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 Group
Participants 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).
Usual Care Control
Usual 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.
Interventions
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Computerized Symptom Capture Tool (C-SCAT) Intervention
The 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
Usual 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.
Eligibility Criteria
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Inclusion Criteria
* Receiving regularly scheduled cancer treatment and will be receiving at least three more cycles
* Reports at least 1 symptom related to cancer and/or its treatment
* Able to speak, read, and write English as required for completion of the C-SCAT and study measures
Exclusion Criteria
15 Years
29 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Ronald Elswick, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
University of Utah Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital @ University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HM20025194
Identifier Type: OTHER
Identifier Source: secondary_id
SSU00210247
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-22-20031
Identifier Type: -
Identifier Source: org_study_id
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