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

NCT05958316 | Recruiting

• 4 other identifiers: MCC-22-20031HM20025194SSU002102471R01CA286799-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

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

Cancer; Symptoms and Signs; Childhood Cancer

Keywords

Supportive Care; Symptom Management

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• 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).

  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).

  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).

  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).

  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).

  2 weeks post intervention (Timepoint 1)

Study Arms (2)

Computerized Symptom Assessment Tool C-SCAT

EXPERIMENTAL

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

Usual Care Control Group

ACTIVE COMPARATOR

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

Interventions

Usual Care Control BEHAVIORAL

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.

Usual Care Control Group

Computerized Symptom Capture Tool (C-SCAT) Intervention BEHAVIORAL

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).

Computerized Symptom Assessment Tool C-SCAT

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- Cognitive and/or physical inability to complete study measures.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

University of Utah Huntsman Cancer Institute (HCI)

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Utah Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Seattle Children's Hospital @ University of Washington

Seattle, Washington, 98105, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Signs and Symptoms; Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ronald Elswick, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Hodges

CONTACT

804-828-8917; hodgesg@vcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: January 4, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)