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

NCT02974569 | Completed

• 2 other identifiers: MCC-16-12876HM20007402
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Symptom Clusters; Cancer

Keywords

adolescents; young adults

Outcome Measures

Primary Outcomes (5)

• 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 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 self-regulation of symptoms assessed by an audio-taped semi-structured interview.

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

  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)

• 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 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)

Study Arms (1)

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

Interventions

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.

Also known as: C-SCAT

C-SCAT

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator
• St. Baldrick's Foundation: collaborator

Study Sites (2)

The Childrens Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suzanne W. Ameringer, Ph.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2016
• First Posted: November 28, 2016
• Study Start: November 1, 2016
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (2)