A Randomized Controlled Trial Using a Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer
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).
Arms & interventions
- BehavioralComputerized 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).
- BehavioralUsual 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.
Outcome measures
Primary
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
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.
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
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.
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
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).
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.
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).
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.
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).
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.
Time frame: 4 weeks following Timepoint 1 (Timepoint 2)
Secondary
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks following Timepoint 1 (Timepoint 2)
Eligibility criteria
Study locations (5)
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Utah Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84112
University of Utah Primary Children's Hospital
Salt Lake City, Utah, 84113
Virginia Commonwealth University
Richmond, Virginia, 23298
Seattle Children's Hospital @ University of Washington
Seattle, Washington, 98105