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Improving Symptom Self-management in Adolescents & Young Adults With Cancer (CSCAT2)

This study is currently recruiting participants.
Verified September 2017 by Virginia Commonwealth University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02974569
First Posted: November 28, 2016
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
St. Baldrick's Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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.

Condition Intervention
Symptom Clusters Cancer Device: Computer Symptom Capture Tool

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Improving Symptom Self-management in Adolescents & Young Adults With Cancer

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 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 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

  • 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 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) ]

Estimated Enrollment: 90
Study Start Date: November 1, 2016
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
C-SCAT
C-SCAT arm: Completes and uses Computerized Symptom Capture Tool (C-SCAT) during visit with provider for two clinic visits.
Device: Computer Symptom Capture Tool
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 Name: C-SCAT

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric and adult oncology clinics at the Virginia Commonwealth University Health System (VCUHS). Patients and parents of minor patients will be approached as inpatients or as outpatients at Massey Cancer Center Fellows Clinic and at the Pediatric Oncology Clinic.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974569


Contacts
Contact: Suzanne W. Ameringer, Ph.D. 804-628-7551 swameringer@vcu.edu
Contact: Amy Heineman 804-828-5242 s2aheine@vcu.edu

Locations
United States, Missouri
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Kristin Stegenga, PhD, MSN    816-302-6841      
Principal Investigator: Kristin Stegenga, PhD, MSN         
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Suzanne W. Ameringer, Ph.D.    804-628-7551    swameringer@vcu.edu   
Contact: Amy Heineman    804-828-5242    s2aheine@vcu.edu   
Principal Investigator: Suzanne W. Ameringer, Ph.D.         
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
St. Baldrick's Foundation
Investigators
Principal Investigator: Suzanne W. Ameringer, Ph.D. Virginia Commonwealth University
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02974569     History of Changes
Other Study ID Numbers: MCC-16-12876
HM20007402 ( Other Identifier: IRB )
First Submitted: November 6, 2016
First Posted: November 28, 2016
Last Update Posted: September 7, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
adolescents
young adults

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes