Clinical trial NCT02974569: Improving Symptom Self-management in Adolescents & Young Adults With Cancer
Official title: Improving Symptom Self-management in Adolescents & Young Adults With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptom Clusters
Cancer
Keywords: adolescents
young adults
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: St. Baldrick's Foundation
First posted: 2016-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Change in self-efficacy of symptom management measured by PROMIS Self-efficacy of symptom management scale.
timeFrame: 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)
measure: Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.
timeFrame: 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)
measure: Change in self-regulation of symptoms assessed by an audio-taped semi-structured interview.
timeFrame: 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)
measure: Change in provider's usefulness of using C-SCAT assessed by Provider Questionnaire.
timeFrame: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
measure: Change in provider's usefulness of using C-SCAT assessed by providers' documentation of symptoms in the electronic health record.
timeFrame: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Childrens Mercy Hospital
state: Missouri
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Suzanne W. Ameringer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: