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

NCT03979846 | Completed DMC

• 3 other identifiers: 19F.163JT 13449R43MD011210
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Caregiver; Malignant Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Arm I (usual care, computer-based symptom reporting)

EXPERIMENTAL

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; Other: Computer Application; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Arm II (computer-based symptom reporting, usual care)

EXPERIMENTAL

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; Other: Computer Application; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm I (usual care, computer-based symptom reporting); Arm II (computer-based symptom reporting, usual care)

Computer Application OTHER

Use computer-based symptom reporting system

Also known as: Application, application software, computer applicaion

Arm I (usual care, computer-based symptom reporting); Arm II (computer-based symptom reporting, usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (usual care, computer-based symptom reporting); Arm II (computer-based symptom reporting, usual care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (usual care, computer-based symptom reporting); Arm II (computer-based symptom reporting, usual care)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (2)

Kennedy Health Systems- Cancer Center

Sewell, New Jersey, 08080, United States

Location

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Ana Maria Lopez, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 7, 2019
• Study Start: March 11, 2019
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)