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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Virginia Commonwealth University
Study ID
NCT05958316
Status
Recruiting

Conditions

  • Cancer
  • Childhood Cancer
  • Symptoms and Signs

Eligibility Criteria

Sex
ALL
Age
15 Years - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • 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).
  • 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.

Study Details

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

Key Dates

Start date
Jan 4, 2024
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Computerized Symptom Assessment Tool C-SCAT
    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).
  • Active Comparator: Usual Care Control Group
    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).

Primary Outcome 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. [ Time Frame: Baseline- Week 0 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Mercy HospitalKansas CityMissouri64108
Kristin Stegenga
816-302-6841
Kristin Stegenga (PRINCIPAL_INVESTIGATOR)
University of Utah Huntsman Cancer Institute (HCI)Salt Lake CityUtah84112
Lauri Linder
801-581-4339
Lauri Linder (PRINCIPAL_INVESTIGATOR)
University of Utah Primary Children's HospitalSalt Lake CityUtah84113
Lauri Linder
801-581-4339
Lauri Linder (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Grace Hodges
804-828-8917
Ronald Elswick, PhD (PRINCIPAL_INVESTIGATOR)
Seattle Children's Hospital @ University of WashingtonSeattleWashington98105-

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