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

Official title

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

Overview

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).

Interventions

• 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 allevia
• 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 treatme

Primary outcome measures

• 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)]

Secondary outcome measures (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). [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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 5 centers

• Children's Mercy Hospital — Kansas City
• University of Utah Huntsman Cancer Institute (HCI) — Salt Lake City
• University of Utah Primary Children's Hospital — Salt Lake City
• Virginia Commonwealth University — Richmond
• Seattle Children's Hospital @ University of Washington — Seattle

Identifiers

NCT: NCT05958316 · MCC-22-20031 · HM20025194 · SSU00210247 · 1R01CA286799-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗