Heuristic Tool To Improve Symptom Self-Management in Adolescents and Young Adults With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-29
SponsorVirginia Commonwealth University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Computerized Symptom Capture Tool (C-SCAT) Intervention
BehavioralThe 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
BehavioralUsual 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Computerized Symptom Assessment Tool C-SCATExperimental treatment 1 intervention
Group B: Usual Care Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 02
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)3
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)4
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 0Secondary outcomes
1
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).
Time frame
Baseline-Week 02
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).
Time frame
2 weeks post intervention (Timepoint 1)3
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).
Time frame
4 weeks following Timepoint 1 (Timepoint 2)4
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).
Time frame
Baseline- Week 0Sponsors and contacts
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Virginia Commonwealth University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov