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Clinical Trials/NCT02974569
NCT02974569
Completed
Not Applicable

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

Virginia Commonwealth University2 sites in 1 country30 target enrollmentNovember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Symptom Clusters
Sponsor
Virginia Commonwealth University
Enrollment
30
Locations
2
Primary Endpoint
Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
October 25, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

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)

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)

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)

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

Study Sites (2)

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