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Trial Title:
Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer
NCT ID:
NCT05958316
Condition:
Symptoms and Signs
Cancer
Childhood Cancer
Conditions: Keywords:
Supportive Care
Symptom Management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Computerized Symptom Capture Tool (C-SCAT) Intervention
Description:
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).
Arm group label:
Computerized Symptom Assessment Tool C-SCAT
Intervention type:
Behavioral
Intervention name:
Usual Care Control
Description:
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.
Arm group label:
Usual Care Control Group
Summary:
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
Detailed description:
This is a multi-site two-group randomized control trial (RCT) design to evaluate the
effects of the Computerized Symptom Assessment Tool (C-SCAT) for improving symptom
self-management versus usual care in 126 adolescents and young adults (AYAs) who are
within the first three months of a diagnosis of cancer and who are receiving cancer
treatment. For this study, cancer treatment will be defined as a prescribed infusion (
e.g., chemotherapy, immunotherapy).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has received at least 1 cycle of cancer treatment and is within 3 months of initial
cancer diagnosis
- 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:
- Cognitive and/or physical inability to complete study measures.
Gender:
All
Minimum age:
15 Years
Maximum age:
29 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Mercy Hospital
Address:
City:
Kansas City
Zip:
64108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristin Stegenga
Phone:
816-302-6841
Email:
kstegenga@cmh.edu
Investigator:
Last name:
Kristin Stegenga
Email:
Principal Investigator
Facility:
Name:
University of Utah Primary Children's Hospital
Address:
City:
Salt Lake City
Zip:
84113
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauri Linder
Phone:
801-581-4339
Email:
lauri.linder@nurs.utah.edu
Investigator:
Last name:
Lauri Linder
Email:
Principal Investigator
Facility:
Name:
Virginia Commonwealth University
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace Hodges
Phone:
804-828-8917
Email:
rkelswic@vcu.edu
Investigator:
Last name:
Ronald Elswick, PhD
Email:
Principal Investigator
Facility:
Name:
Seattle Children's Hospital @ University of Washington
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine F Macpherson
Phone:
206-987-2032
Email:
CatherineFiona.Macpherson@seattlechildrens.org
Investigator:
Last name:
Catherine F Macpherson
Email:
Principal Investigator
Start date:
January 4, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Virginia Commonwealth University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Virginia Commonwealth University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05958316
