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

November 22, 2019 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

Intervention / Treatment

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

  • United States
    • 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

Genders Eligible for Study

All

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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
Other: Computer Application
Use computer-based symptom reporting system
Other Names:
  • Application
  • application software
  • computer applicaion
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
Other: Computer Application
Use computer-based symptom reporting system
Other Names:
  • Application
  • application software
  • computer applicaion

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

Thomas Jefferson University

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)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19F.163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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