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

Thomas Jefferson University

Status: Completed

Conditions: Malignant Neoplasm; Caregiver

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03979846

R43MD011210 (U.S. NIH Grant/Contract)

19F.163

JT 13449 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Computer Application

Other: Best Practice

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

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Computer Application

Other: Best Practice