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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979846
• Other study ID #: 19F.163
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: May 29, 2019

Study information

• Verified date: November 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Computer Application
Use computer-based symptom reporting system
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hopsital	Philadelphia	Pennsylvania
United States	Kennedy Health Systems- Cancer Center	Sewell	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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