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

NCT ID: NCT05958316

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-04

Study Completion Date

2026-08-31

Brief Summary

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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

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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).

Conditions

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Symptoms and Signs Cancer Childhood Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Computerized Symptom Capture Tool (C-SCAT) Intervention

Intervention Type 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 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).

Group Type ACTIVE_COMPARATOR

Usual Care Control

Intervention Type 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.

Interventions

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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 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).

Intervention Type 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 treatment; 3) ask if anything has changed with their treatment plan since the last study visit; and 4) confirm continued participation in the study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Elswick, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status RECRUITING

University of Utah Primary Children's Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Seattle Children's Hospital @ University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Grace Hodges

Role: CONTACT

804-828-8917

Facility Contacts

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Kristin Stegenga

Role: primary

816-302-6841

Lauri Linder

Role: primary

801-581-4339

Grace Hodges

Role: primary

804-828-8917

Catherine F Macpherson

Role: primary

206-987-2032

Other Identifiers

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HM20025194

Identifier Type: OTHER

Identifier Source: secondary_id

SSU00210247

Identifier Type: OTHER

Identifier Source: secondary_id

1R01CA286799-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-22-20031

Identifier Type: -

Identifier Source: org_study_id

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