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Completed

NCT Number: NCT02974569

Improving Symptom Self-management in Adolescents & Young Adults With Cancer

This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates an image of the symptoms the participant is experiencing, for improving symptom self-management in adolescents and young adults with cancer. In this one-group trial, participants will complete the C-SCAT and use it during two clinic visits with their oncology providers.

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Key information

Conditions

Symptom Clusters Cancer Disease Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Syndrome

Age range

15 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Childrens Mercy Hospital, Kansas City, Missouri, United States

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About this study

Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs) with cancer. Strategies are needed to help AYAs manage symptoms. The investigators developed the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs create a picture of their symptoms using images and text on an iPad app. The resulting image shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has potential to support AYA's symptom self-management. Facilitating the self-management process, including self-efficacy, self-regulation behaviors, and patient-provider communication, is essential for improving symptom outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 15 to 29 years of age with a diagnosis of cancer (primary, relapsed/recurrent, refractory, progressive, or secondary malignancy) receiving myelosuppressive chemotherapy.
  • Completion of at least one cycle of therapy for cancer and anticipated to have at least two additional cycles of myelosuppressive chemotherapy as part of the treatment plan.
  • Ability to speak and understand English as required to complete the C-SCAT and study measures.
  • Ability to use a tablet computer.

Exclusion criteria

  • Cognitive and/or physical inabilities to complete the proposed study measures as determined by self--report, parent report of minor, or medical chart.

Treatment and study plan

Computer Symptom Capture Tool

Device

C-SCAT is an investigator developed app that is delivered via an iPad. The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale. The recently updated version includes two additional symptoms "feeling bloated" and "sexual dysfunction" that are included in the adult version of the MSAS.21 These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience.

Other names: C-SCAT

Primary outcomes

  1. Change in self-efficacy of symptom management measured by PROMIS Self-efficacy of symptom management scale.

    Time frame: Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)

  2. Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.

    Time frame: Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)

  3. Change in self-regulation of symptoms assessed by an audio-taped semi-structured interview.

    Time frame: Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)

    Semi-structured interviews to address how using the C-SCAT impacts self-regulation behaviors, such as self-monitoring, reflective thinking, and decision-making

  4. Change in provider's usefulness of using C-SCAT assessed by Provider Questionnaire.

    Time frame: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)

  5. Change in provider's usefulness of using C-SCAT assessed by providers' documentation of symptoms in the electronic health record.

    Time frame: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Cancer Institute (NCI)
  • St. Baldrick's Foundation

Registry information

Acronym: CSCAT2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 28, 2016
Registry last updated
Dec 22, 2017

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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