A Computer-Based System for Symptom Reporting in Patients With Cancer Undergoing Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Assessment of a Digital System for Cancer Patient Symptom Reporting

Conditions
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Caregiver, Malignant Neoplasm

Intervention / Treatment
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* Other: Best Practice
* Other: Computer Application
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (usual care, computer-based symptom reporting)<br>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. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Computer Application<br>* Use computer-based symptom reporting system<br>* Other names: computer applicaion;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Experimental: Arm II (computer-based symptom reporting, usual care)<br>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. | Other: Best Practice<br>* Receive usual care<br>* Other names: standard therapy;Other: Computer Application<br>* Use computer-based symptom reporting system<br>* Other names: computer applicaion;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the computer-based symptom reporting system | 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 | 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) | 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) | 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 |