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NCT Number: NCT05958316

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

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

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Key information

Conditions

Symptoms and Signs Cancer Childhood Cancer Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital, Kansas City, Missouri, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: Baseline- Week 0

    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

  2. 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)

    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

  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.

    Time frame: 4 weeks following Timepoint 1 (Timepoint 2)

    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

  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).

    Time frame: Baseline- Week 0

    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.

  5. 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)

    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.

  6. 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)

    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.

Secondary 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).

    Time frame: Baseline-Week 0

    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).

  2. 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)

    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).

  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).

    Time frame: 4 weeks following Timepoint 1 (Timepoint 2)

    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).

  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).

    Time frame: Baseline- Week 0

    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).

  5. 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)

    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).

  6. 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)

    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).

  7. 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

    Quality of life (QOL) social function will be assessed with the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities. It contains 8 items, is scored on a 5-point Likert response scale (5=never; 1=always)

  8. 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)

    Quality of life (QOL) social function will be assessed with the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities. It contains 8 items, is scored on a 5-point Likert response scale (5=never; 1=always)

  9. 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)

    Quality of life (QOL) social function will be assessed with the PROMIS SF v2.0 Ability to Participate in Social Roles and Activities. It contains 8 items, is scored on a 5-point Likert response scale (5=never; 1=always)

  10. 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

    QOL satisfaction with social function will be assessed with the PROMIS SF v2.0 Satisfaction with Social Roles and Activities. It contains eight items, is scored on a 5-point Likert response scale (1=not at all; 5=very much)

  11. 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)

    QOL satisfaction with social function will be assessed with the PROMIS SF v2.0 Satisfaction with Social Roles and Activities. It contains eight items, is scored on a 5-point Likert response scale (1=not at all; 5=very much)

  12. 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)

    QOL satisfaction with social function will be assessed with the PROMIS SF v2.0 Satisfaction with Social Roles and Activities. It contains eight items, is scored on a 5-point Likert response scale (1=not at all; 5=very much)

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Hodges

CONTACT

[email protected]

804-828-8917

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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