Caregiver, Malignant Neoplasm
Conditions
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.
Interventions
OTHERBest Practice
Receive usual care
OTHERComputer Application
Use computer-based symptom reporting system
OTHERQuestionnaire Administration
Ancillary studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of the computer-based symptom reporting system | 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 | 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) | 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) | 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. |
Countries
United States
Outcome results
None listed