Clinical trial NCT05958316: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptoms and Signs
Cancer
Childhood Cancer
Keywords: Supportive Care
Symptom Management
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-24
Enrollment: 126
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
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.
timeFrame: Baseline- Week 0
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.
timeFrame: 2 weeks post intervention (Timepoint 1)
measure: 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.
timeFrame: 4 weeks following Timepoint 1 (Timepoint 2)
measure: 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).
timeFrame: Baseline- Week 0
measure: 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).
timeFrame: 2 weeks post intervention (Timepoint 1)
measure: 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).
timeFrame: 4 weeks following Timepoint 1 (Timepoint 2)
Secondary outcomes:
measure: 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).
timeFrame: Baseline-Week 0
measure: 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).
timeFrame: 2 weeks post intervention (Timepoint 1)
measure: 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).
timeFrame: 4 weeks following Timepoint 1 (Timepoint 2)
measure: 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).
timeFrame: Baseline- Week 0
measure: 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).
timeFrame: 2 weeks post intervention (Timepoint 1)
measure: 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).
timeFrame: 4 weeks following Timepoint 1 (Timepoint 2)
measure: 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.
timeFrame: Baseline- Week 0
measure: 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.
timeFrame: 2 weeks post intervention (Timepoint 1)
measure: 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.
timeFrame: 4 weeks following Timepoint 1 (Timepoint 2)
measure: 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.
timeFrame: Baseline -week 0
measure: 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.
timeFrame: 2 weeks post intervention (Timepoint 1)
measure: 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.
timeFrame: 4 weeks following Timepoint 1 (Timepoint 2)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Salt Lake City
country: United States
facility: University of Utah Primary Children's Hospital
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital @ University of Washington
state: Washington
Study officials:
affiliation: Virginia Commonwealth University
name: Ronald Elswick, PhD
role: PRINCIPAL_INVESTIGATOR
References: