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

Completed

• Conditions: Cancer; Symptom Clusters
• Interventions: Device: Computer Symptom Capture Tool

• Registration Number: NCT02974569
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2016-11-06
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C-SCAT	Computer Symptom Capture Tool	C-SCAT arm: Completes and uses Computerized Symptom Capture Tool (C-SCAT) during visit with provider for two clinic visits.

Primary Outcome Measures

Name	Time	Method
Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.	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.	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.	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.	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.	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

Trial Locations

Locations (2)

The Childrens Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States