A Pilot Assessment of a Digital System for Cancer Patient Symptom Reporting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Usability of the computer-based symptom reporting system
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Usability of the computer-based symptom reporting system
Time Frame: 6 weeks
Assessed with the System Usability Scale (SUS). The SUS is a 10-item 5-point Likert scale usability measure, scored from 0 (least usable) to 100 (most usable). The mean SUS scores (only during the active cancer treatment) will be computed with the corresponding 90% confidence intervals.
Patient-deemed usefulness of computer-based symptom reporting system
Time Frame: 6 weeks
Assessed with the Perceived System Usefulness (PSU) scale. The mean PSU scores (only during the active cancer treatment) will be computed with the corresponding 90% confidence intervals.
Effectiveness of the computer-based symptom reporting system (FACT-G)
Time Frame: 6 weeks
Evaluated using the quality of life outcome Functional Assessment of Cancer Therapy - General (FACT-G) scale. For the FACT-G, the 4 repeated measures (excluding the baseline) will be analyzed in linear mixed effects models with the random effect of user group (patient and caregiver) and fixed effect of period, sequence. The model will be used to compute the 90% confidence intervals for the mean FACT-G on usual care and on the digital system.
Effectiveness of the computer-based symptom reporting system (CDSES-R)
Time Frame: 6 weeks
Evaluated using the self-efficacy Chronic Disease Self-Efficacy Scale, Revised (CDSES-R) scale. For the CDSES-R, the 4 repeated measures (excluding the baseline) will be analyzed in linear mixed effects models with the random effect of user group (patient and caregiver) and fixed effect of period, sequence. The model will be used to compute the 90% confidence intervals for the mean CDSES-R on usual care and on the digital system.
Secondary Outcomes
No secondary outcomes reported