A Computer-Based System for Symptom Reporting in Patients With Cancer Undergoing Treatment
May 19, 2025 updated by: Thomas Jefferson University
A Pilot Assessment of a Digital System for Cancer Patient Symptom Reporting
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Sewell, New Jersey, United States, 08080
- Kennedy Health Systems- Cancer Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hopsital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (usual care, computer-based symptom reporting)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Receive usual care
Other Names:
Use computer-based symptom reporting system
Other Names:
|
|
Experimental: Arm II (computer-based symptom reporting, usual care)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Receive usual care
Other Names:
Use computer-based symptom reporting system
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ana Maria Lopez, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2019
Primary Completion (Actual)
May 29, 2019
Study Completion (Actual)
May 29, 2019
Study Registration Dates
First Submitted
May 28, 2019
First Submitted That Met QC Criteria
June 6, 2019
First Posted (Actual)
June 7, 2019
Study Record Updates
Last Update Posted (Actual)
May 22, 2025
Last Update Submitted That Met QC Criteria
May 19, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19F.163
- JT 13449 (Other Identifier: JeffTrial Number)
- R43MD011210 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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