Clinical trial NCT03979846: A Computer-Based System for Symptom Reporting in Patients With Cancer Undergoing Treatment
Official title: A Pilot Assessment of a Digital System for Cancer Patient Symptom Reporting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Malignant Neoplasm
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot trial studies the usability and usefulness of a computer-based system for reporting symptoms in patients with cancer undergoing treatment. Cancer patients undergoing cancer treatment are not always comfortable contacting the doctor when experiencing symptoms. A computer based platform, where patients can input symptoms, may seem less intrusive than a phone call and may improve patient access to care.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the usability and usefulness of a computer-based system for cancer patient symptom reporting.

SECONDARY OBJECTIVES:

I. To collect preliminary effectiveness data: quality of life outcomes with the Function Assessment of Cancer Therapy - General (FACT-G) and self-efficacy as measured by Chronic Disease Self-Efficacy Scale, Revised (CDSES-R).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive usual care for 3 weeks, then use a computer-based symptom reporting system for 3 weeks. Caregivers may assist patients in the use of the computer based symptoms reporting system.

ARM II: Participants use a computer-based symptom reporting system for 3 weeks, then receive usual care for 3 weeks. Caregivers may assist patients in the use of the computer based symptoms reporting system.

After completing study intervention, participants are followed up for 30 days.

Eligibility criteria: Inclusion Criteria:

* PATIENT: Active outpatient cancer treatment (chemotherapy, immunotherapy, radiation, and hormonal therapy)
* PATIENT: No clinical evidence of cognitive or psychological impairment.
* PATIENT: Home internet access on computer or phone.
* CAREGIVER: Selected family member or close friend of the cancer patient matching the patient inclusion criteria outlined above.

Exclusion Criteria:

* Inability to provide informed consent.

Primary outcomes:
measure: Usability of the computer-based symptom reporting system
timeFrame: 6 weeks
measure: Patient-deemed usefulness of computer-based symptom reporting system
timeFrame: 6 weeks
measure: Effectiveness of the computer-based symptom reporting system (FACT-G)
timeFrame: 6 weeks
measure: Effectiveness of the computer-based symptom reporting system (CDSES-R)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sewell
country: United States
facility: Kennedy Health Systems- Cancer Center
state: New Jersey
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hopsital
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Ana Maria Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: