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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the C-SCAT treatment 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 discussions and improved symptom management plans. Providers reported that the tool helped identify patients' symptoms and priorities, which facilitated the development of effective management strategies. ^{1 2 3 4 5}

Is the C-SCAT tool safe for use in young adults with cancer?

The C-SCAT tool, used to help understand symptoms in young adults with cancer, has been studied for its feasibility and acceptability, but specific safety data is not provided in the available research. However, it is a non-invasive tool that involves using an iPad application to report symptoms, suggesting it is generally safe for use. ^{1 3 6 7 8}

How is the C-SCAT treatment different from other treatments for young adult cancer management?

The C-SCAT treatment is unique because it uses an iPad application to help young adults with cancer identify and communicate their symptoms more effectively, allowing for more personalized symptom management compared to standard care. ^{1 2 3 9 10}

Research Team

Ronald Elswick, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an iPad application to explore symptom clusters in adolescents and young adults with cancer. [2014]

2. Scotland pubmed.ncbi.nlm.nih.gov

Piloting electronic self report symptom assessment - Cancer (ESRA-C) in Hong Kong: a mixed method approach. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Adolescents and Young Adults with Cancer Using a Symptom Heuristics App: Provider Perceptions and Actions. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Symptom profiles in children with advanced cancer: Patient, family caregiver, and oncologist ratings. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Validation of the Cancer Care Monitor items for physical symptoms and treatment side effects using expert oncology nurse evaluation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Capturing the patient perspective: patient-reported outcomes as clinical trial endpoints. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Electronic toxicity monitoring and patient-reported outcomes. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Symptoms and Symptom Clusters Identified by Adolescents and Young Adults With Cancer Using a Symptom Heuristics App. [2015]

10. Germany pubmed.ncbi.nlm.nih.gov

Symptom self-management strategies reported by adolescents and young adults with cancer receiving chemotherapy. [2018]