Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer

A Randomized Controlled Trial Using a Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Cancer; Childhood Cancer; Symptoms and Signs
• Intervention / Treatment: Behavioral: Computerized Symptom Capture Tool (C-SCAT) Intervention; Behavioral: Usual Care Control

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).

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Hodges; Phone Number: 804-828-8917; Email: hodgesg@vcu.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Hospital
      • Contact: Kristin Stegenga; Phone Number: 816-302-6841; Email: kstegenga@cmh.edu
      • Principal Investigator: Kristin Stegenga
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Recruiting
      • University of Utah Primary Children's Hospital
      • Contact: Lauri Linder; Phone Number: 801-581-4339; Email: lauri.linder@nurs.utah.edu
      • Principal Investigator: Lauri Linder
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah Huntsman Cancer Institute (HCI)
      • Contact: Lauri Linder; Phone Number: 801-581-4339; Email: lauri.linder@nurs.utah.edu
      • Principal Investigator: Lauri Linder
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Grace Hodges; Phone Number: 804-828-8917; Email: rkelswic@vcu.edu
      • Principal Investigator: Ronald Elswick, PhD
  • Washington
    • Seattle, Washington, United States, 98105
      • Active, not recruiting
      • Seattle Children's Hospital @ University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has received at least 1 cycle of cancer treatment and is within 3 months of receiving that first cycle of treatment
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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).
Active Comparator: 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).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Self-efficacy for symptom management will be assessed with the PROMIS® Self Efficacy for Symptom Management Scale that contains 28 items and assess the person's current level of confidence to manage/control symptoms, manage symptoms in different settings, and keep symptoms from interfering with work, relationships, or activities. Response options are on a 5-point Likert scale (1=I am not confident at all; 5=I am very confident). Scores are summed across items, and higher scores indicate greater self-efficacy	Baseline- Week 0
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.	Self-efficacy for symptom management will be assessed with the PROMIS® Self Efficacy for Symptom Management Scale that contains 28 items and assess the person's current level of confidence to manage/control symptoms, manage symptoms in different settings, and keep symptoms from interfering with work, relationships, or activities. Response options are on a 5-point Likert scale (1=I am not confident at all; 5=I am very confident). Scores are summed across items, and higher scores indicate greater self-efficacy	2 weeks post intervention (Timepoint 1)
Effects of the C-SCAT versus usual care on the primary outcomes of self-efficacy for symptom management at follow up (Time 2) by comparing the scores from the Patient-Reported Outcomes Measurement Information System®; PROMIS® Scale.	Self-efficacy for symptom management will be assessed with the PROMIS® Self Efficacy for Symptom Management Scale that contains 28 items and assess the person's current level of confidence to manage/control symptoms, manage symptoms in different settings, and keep symptoms from interfering with work, relationships, or activities. Response options are on a 5-point Likert scale (1=I am not confident at all; 5=I am very confident). Scores are summed across items, and higher scores indicate greater self-efficacy	4 weeks following Timepoint 1 (Timepoint 2)
Effects of the C-SCAT versus usual care on the primary outcomes of symptom self-management behaviors immediately post intervention (Time 1) by comparing the scores from the Symptom Self-management Behaviors Tool (SSMBT).	The SSMBT contains 12 items with two subscales: Manage Symptoms (8 items) that addresses behaviors related to managing their symptoms, and Talk to Healthcare Provider (4 items) that addresses behaviors related to communicating with their HCP about their symptoms. Items are scored using a 5-point Likert scale (0=never/rarely; 4=always). Scores are summed across all items. Higher scores indicate higher engagement in SS-M behaviors.	Baseline- Week 0
Effects of the C-SCAT versus usual care on the primary outcomes of symptom self-management behaviors immediately post intervention (Time 1) by comparing the scores from the Symptom Self-management Behaviors Tool (SSMBT).	The SSMBT contains 12 items with two subscales: Manage Symptoms (8 items) that addresses behaviors related to managing their symptoms, and Talk to Healthcare Provider (4 items) that addresses behaviors related to communicating with their HCP about their symptoms. Items are scored using a 5-point Likert scale (0=never/rarely; 4=always). Scores are summed across all items. Higher scores indicate higher engagement in SS-M behaviors.	2 weeks post intervention (Timepoint 1)
Effects of the C-SCAT versus usual care on the primary outcomes of symptom self-management behaviors at follow up (Time 2) by comparing the scores from the Symptom Self-management Behaviors Tool (SSMBT).	The SSMBT contains 12 items with two subscales: Manage Symptoms (8 items) that addresses behaviors related to managing their symptoms, and Talk to Healthcare Provider (4 items) that addresses behaviors related to communicating with their HCP about their symptoms. Items are scored using a 5-point Likert scale (0=never/rarely; 4=always). Scores are summed across all items. Higher scores indicate higher engagement in SS-M behaviors.	4 weeks following Timepoint 1 (Timepoint 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of the C-SCAT versus usual care on secondary outcomes (symptom severity) at baseline, by comparing the scores from the Memorial Symptom Assessment Scale (MSAS).	Symptom severity in the past week will be assessed with the Memorial Symptom Assessment Scale (MSAS). Participants rate the severity on a 4-point Likert scale (1=slightly; 4=very severe), and the distress on a 5-point Likert scale (0=none; 4=very much).	Baseline-Week 0
Effects of the C-SCAT versus usual care on secondary outcomes (symptom severity) immediately post intervention (Time 1) by comparing the scores from the Memorial Symptom Assessment Scale (MSAS).	Symptom severity in the past week will be assessed with the Memorial Symptom Assessment Scale (MSAS). Participants rate the severity on a 4-point Likert scale (1=slightly; 4=very severe), and the distress on a 5-point Likert scale (0=none; 4=very much).	2 weeks post intervention (Timepoint 1)
Effects of the C-SCAT versus usual care on secondary outcomes (symptom severity) immediately post intervention (Time 2) by comparing the scores from the Memorial Symptom Assessment Scale (MSAS).	Symptom severity in the past week will be assessed with the Memorial Symptom Assessment Scale (MSAS). Participants rate the severity on a 4-point Likert scale (1=slightly; 4=very severe), and the distress on a 5-point Likert scale (0=none; 4=very much).	4 weeks following Timepoint 1 (Timepoint 2)
Effects of the C-SCAT versus usual care on secondary outcomes (symptom distress), at baseline, by comparing the scores from the Memorial Symptom Assessment Scale (MSAS).	Symptom distress in the past week will be assessed with the Memorial Symptom Assessment Scale (MSAS). Participants rate the distress on a 4-point Likert scale (1=slightly; 4=very severe), and the distress on a 5-point Likert scale (0=none; 4=very much).	Baseline- Week 0
Effects of the C-SCAT versus usual care on secondary outcomes (symptom distress) immediately post intervention (Time 1) by comparing the scores from the Memorial Symptom Assessment Scale (MSAS).	Symptom distress in the past week will be assessed with the Memorial Symptom Assessment Scale (MSAS). Participants rate the distress on a 4-point Likert scale (1=slightly; 4=very severe), and the distress on a 5-point Likert scale (0=none; 4=very much).	2 weeks post intervention (Timepoint 1)
Effects of the C-SCAT versus usual care on secondary outcomes (symptom distress) immediately post intervention (Time 2) by comparing the scores from the Memorial Symptom Assessment Scale (MSAS).	Symptom distress in the past week will be assessed with the Memorial Symptom Assessment Scale (MSAS). Participants rate the distress on a 4-point Likert scale (1=slightly; 4=very severe), and the distress on a 5-point Likert scale (0=none; 4=very much).	4 weeks following Timepoint 1 (Timepoint 2)
Effects of the C-SCAT versus usual care on secondary outcomes (social function) at baseline, by comparing the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities scores.	Quality of life (QOL) social function will be assessed with the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities. It contains 8 items, is scored on a 5-point Likert response scale (5=never; 1=always)	Baseline- Week 0
Effects of the C-SCAT versus usual care on secondary outcomes (social function) immediately post intervention (Time 1) by comparing the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities scores.	Quality of life (QOL) social function will be assessed with the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities. It contains 8 items, is scored on a 5-point Likert response scale (5=never; 1=always)	2 weeks post intervention (Timepoint 1)
Effects of the C-SCAT versus usual care on secondary outcomes (social function) post intervention (Time 2) by comparing the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities scores.	Quality of life (QOL) social function will be assessed with the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities. It contains 8 items, is scored on a 5-point Likert response scale (5=never; 1=always)	4 weeks following Timepoint 1 (Timepoint 2)
Effects of the C-SCAT versus usual care on secondary outcomes (satisfaction with social function) post intervention (Time 2) by comparing the PROMIS SF v2.0 Satisfaction with Social Roles and Activities.	QOL satisfaction with social function will be assessed with the PROMIS SF v2.0 Satisfaction with Social Roles and Activities. It contains eight items, is scored on a 5-point Likert response scale (1=not at all; 5=very much)	Baseline -week 0
Effects of the C-SCAT versus usual care on secondary outcomes (satisfaction with social function) post intervention (Time 2) by comparing the PROMIS SF v2.0 Satisfaction with Social Roles and Activities.	QOL satisfaction with social function will be assessed with the PROMIS SF v2.0 Satisfaction with Social Roles and Activities. It contains eight items, is scored on a 5-point Likert response scale (1=not at all; 5=very much)	2 weeks post intervention (Timepoint 1)
Effects of the C-SCAT versus usual care on secondary outcomes (satisfaction with social function) post intervention (Time 2) by comparing the PROMIS SF v2.0 Satisfaction with Social Roles and Activities.	QOL satisfaction with social function will be assessed with the PROMIS SF v2.0 Satisfaction with Social Roles and Activities. It contains eight items, is scored on a 5-point Likert response scale (1=not at all; 5=very much)	4 weeks following Timepoint 1 (Timepoint 2)

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ronald Elswick, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Supportive Care; Symptom Management
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Neoplasms; Signs and Symptoms; Investigative Techniques; Methods
• Other Study ID Numbers: MCC-22-20031; HM20025194 (Other Identifier: Virginia Commonwealth University); SSU00210247 (Other Identifier: Advarra); 1R01CA286799-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No