C-SCAT for Young Adult Cancer Management

Recruiting at 3 trial locations

Overseen By Grace Hodges

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Cognitive, physical inability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the Computerized Symptom Capture Tool (C-SCAT) helps young adults manage cancer symptoms compared to usual care. Participants in the experimental group will use the C-SCAT during treatment visits to track and manage symptoms more effectively. The study seeks individuals who have recently started cancer treatment, are experiencing symptoms related to their cancer or its treatment, and will continue treatment for at least three more cycles. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance symptom management for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current cancer treatments, as the trial involves comparing a new tool to usual care.

What prior data suggests that the Computerized Symptom Assessment Tool (C-SCAT) is safe for young adults?

Research has shown that the Computerized Symptom Assessment Tool (C-SCAT) has been tested for ease of use and acceptability among young adults with cancer. Specific safety information for C-SCAT is not available. It is important to note that C-SCAT is a digital tool designed to help understand and manage symptoms, not a medication or physical treatment, which usually means a lower risk of physical side effects. The study phase is labeled "Not Applicable," indicating that the main goal is to assess the tool's effectiveness, not to evaluate serious safety issues. Therefore, although detailed safety data is lacking, the nature of the tool suggests it is likely safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the C-SCAT because it offers a more personalized way to manage cancer symptoms in young adults. Unlike standard care, which relies on regular clinic visits and verbal symptom reports, the C-SCAT uses a computerized tool to capture symptoms more frequently and accurately. This innovative approach allows for real-time tracking and potentially quicker adjustments to treatment plans, aiming to enhance overall patient care and quality of life.

What evidence suggests that the Computerized Symptom Assessment Tool (C-SCAT) is effective for young adult cancer management?

In this trial, participants in one arm will use the Computerized Symptom Capture Tool (C-SCAT) to help doctors and nurses better identify and manage symptoms in young adults with cancer. Research has shown that in a previous study, 50% of healthcare providers reported that C-SCAT improved symptom identification. This tool increases patients' awareness and understanding of their symptoms. By using C-SCAT, patients may feel more in control of managing their symptoms. Overall, C-SCAT aims to enhance communication between patients and healthcare providers, potentially leading to better cancer care. Participants in the other arm will receive usual care for cancer symptoms. ^{1 2 4 6 7}

Who Is on the Research Team?

Ronald Elswick, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents and young adults who have been diagnosed with cancer within the last 3 months, have undergone at least one treatment cycle, and will undergo at least three more. They should be experiencing at least one symptom from their condition or treatment but must not have cognitive or physical issues that would prevent them from participating in the study.

Inclusion Criteria

I experience symptoms due to my cancer or its treatment.

Able to speak, read, and write English as required for completion of the C-SCAT and study measures

I started cancer treatment within 3 months of my diagnosis and have completed at least 1 cycle.

Exclusion Criteria

I am able to complete study tasks and understand instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cancer treatment and complete the C-SCAT at three clinic visits over a period of up to 12 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for self-efficacy and symptom management behaviors post intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Symptom Capture Tool (C-SCAT) Intervention
• Usual Care Control

Trial Overview The study is testing a Computerized Symptom Capture Tool (C-SCAT) against usual care to see if it improves how confident patients feel about managing their symptoms and whether it changes how they actually manage those symptoms.

How Is the Trial Designed?

Group I: Computerized Symptom Assessment Tool C-SCAT Experimental Treatment 1 Intervention

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 II: Usual Care Control Group Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 72 adolescents and young adults with cancer revealed that they commonly experience multiple distressing symptoms during chemotherapy, with nausea being the most frequently reported symptom.

The use of an iPad-based application (C-SCAT) allowed participants to visually express their symptoms and symptom clusters, highlighting the complexity of their experiences and emphasizing the need for personalized symptom management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms and Symptom Clusters Identified by Adolescents and Young Adults With Cancer Using a Symptom Heuristics App. Ameringer, S., Erickson, JM., Macpherson, CF., et al.[2015]

The Electronic Self Report Assessment - Cancer (ESRA-C) tool was found to be moderately acceptable among 30 Chinese oncology patients, with participants reporting it as useful for tracking their health conditions.

The study indicates that using electronic symptom assessments can improve the management of symptoms in cancer patients, as it provides a feasible and effective way to regularly monitor their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting electronic self report symptom assessment - Cancer (ESRA-C) in Hong Kong: a mixed method approach. Chan, CW., Tam, W., Cheng, KK., et al.[2011]

The Cancer Care Monitor (CCM) effectively measures symptom burden and quality of life in cancer patients, showing strong agreement between patient self-reports and nurse evaluations based on a study of 60 patients (40 females and 20 males).

The CCM demonstrated high sensitivity and specificity for most items, indicating it is a reliable tool for assessing symptoms and treatment side effects in real-time during patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Cancer Care Monitor items for physical symptoms and treatment side effects using expert oncology nurse evaluation. Fortner, B., Baldwin, S., Schwartzberg, L., et al.[2019]

Current methods for capturing patient symptoms in clinical trials, like the National Cancer Institute Common Terminology Criteria for Adverse Events (CTC[AE]), often lead to inaccuracies due to multiple layers of interpretation, which can result in underreporting or overreporting of symptoms.

Implementing patient-reported outcomes (PROs) directly from patients can improve data accuracy and provide valuable insights into symptom prevalence and severity, suggesting that routine PRO reporting should be integrated alongside traditional methods in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capturing the patient perspective: patient-reported outcomes as clinical trial endpoints. Bruner, DW., Movsas, B., Basch, E.[2020]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

The Computerized Symptom Capture Tool (C-SCAT) was found to be useful by 50% of healthcare providers in identifying symptoms of adolescents and young adults (AYAs) with cancer, leading to more focused discussions and better engagement during consultations.

The C-SCAT helped prioritize symptoms more effectively, with priority symptoms documented 54% of the time compared to 32.7% for nonpriority symptoms, indicating its potential to improve symptom management plans for AYAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents and Young Adults with Cancer Using a Symptom Heuristics App: Provider Perceptions and Actions. Macpherson, CF., Stegenga, K., Erickson, JM., et al.[2022]

A study involving 72 adolescents and young adults (ages 13-29) with cancer identified 772 unique self-management strategies for symptoms related to their illness and treatment, highlighting the importance of individualized approaches.

The most common self-management strategy reported was the use of medications, but participants also engaged in physical and psychosocial care activities, indicating a holistic approach to managing their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom self-management strategies reported by adolescents and young adults with cancer receiving chemotherapy. Linder, LA., Erickson, JM., Stegenga, K., et al.[2018]

In a study involving 60 pediatric oncology patients, common symptoms included fatigue and pain, highlighting the need for systematic symptom assessment in this population.

There was often a lack of agreement between children's self-reports and caregiver reports of symptoms, which may contribute to inadequate treatment recommendations from oncologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom profiles in children with advanced cancer: Patient, family caregiver, and oncologist ratings. Zhukovsky, DS., Rozmus, CL., Robert, RS., et al.[2018]

The Computerized Symptom Capture Tool (C-SCAT) was successfully completed by 72 adolescents and young adults with cancer, taking an average of 25 minutes, indicating its feasibility and acceptability for this population.

Participants found the C-SCAT effective in accurately representing their symptoms, with 74% agreeing that the final image reflected their experiences, suggesting it could enhance communication between patients and healthcare providers for better symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an iPad application to explore symptom clusters in adolescents and young adults with cancer. Macpherson, CF., Linder, LA., Ameringer, S., et al.[2014]

Direct patient reporting of adverse events in cancer treatment through electronic interfaces may improve the accuracy and completeness of symptom reporting, addressing the issue of underreporting by clinical staff.

The National Cancer Institute is developing and testing a new system called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, which aims to enhance the collection of adverse symptom information from patients in clinical research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic toxicity monitoring and patient-reported outcomes. Basch, EM., Reeve, BB., Mitchell, SA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7578178/

Adolescents and Young Adults with Cancer Using a ... Seventy-two (50%) of provider responses indicated that the C-SCAT helped identify the patient's symptoms, 59 (42%) of responses indicated it helped identify ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05958316

NCT05958316 | Heuristic Tool To Improve Symptom Self ... 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 ...

3. reporter.nih.gov reporter.nih.gov/project-details/11136270

Project Details - NIH RePORTER The Computerized Symptom Capture Tool (C-SCAT) is an intervention that uses a heuristics approach to promote AYAs' self-awareness and insight about themselves ...

4. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R01CA286799

Funded Grants | Division of Cancer Prevention The Computerized Symptom Capture Tool (C-SCAT) is an intervention that uses a heuristics approach to promote AYAs' self-awareness and insight about themselves ...

5. withpower.com withpower.com/trial/phase-signs-and-symptoms-7-2023-40b32

C-SCAT for Young Adult Cancer Management The C-SCAT treatment has been shown to help healthcare providers better understand and manage symptoms in young adults with cancer, leading to more focused ...

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct05958316

Heuristic Tool To Improve Symptom Self-Management in ... Determine the effects of the Computerized Symptom Assessment Tool (C-SCAT) versus usual care on the primary outcomes of self-efficacy for symptom management ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03336

A Computerized Tool (C-SCAT) to Improve Symptom Self ... This clinical trial is being done to see if using the Computerized Symptom Capture Tool (C-SCAT) improves symptom self-management in adolescents and young ...