Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT05958316

Conditions

Symptoms and Signs

Cancer

Childhood Cancer

Eligibility Criteria

Sex: All

Age: 15 - 29

Healthy Volunteers: Not accepted

Interventions

Computerized Symptom Capture Tool (C-SCAT) Intervention

Usual Care Control

Study Details

Brief 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

Conditions

Symptoms and Signs

Cancer

Childhood Cancer

Study ID

NCT05958316

Start date

Jan 4, 2024

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 29

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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.

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 ]
  • 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: 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. [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 4 weeks following Timepoint 1 (Timepoint 2) ]

Central Contacts and Locations

Central contacts

Grace Hodges

804-828-8917hodgesg@vcu.edu

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Kristin Stegenga

816-302-6841kstegenga@cmh.edu

Principal Investigator:

Kristin Stegenga

University of Utah Huntsman Cancer Institute (HCI)

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Lauri Linder

801-581-4339lauri.linder@nurs.utah.edu

Principal Investigator:

Lauri Linder

University of Utah Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Lauri Linder

801-581-4339lauri.linder@nurs.utah.edu

Principal Investigator:

Lauri Linder

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Grace Hodges

804-828-8917rkelswic@vcu.edu

Principal Investigator:

Ronald Elswick, PhD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Supportive Care
  • Symptom Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-05-22.