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

NCT ID: NCT03979846

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2019-05-29

Brief Summary

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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

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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.

Conditions

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Caregiver Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive usual care

Computer Application

Intervention Type OTHER

Use computer-based symptom reporting system

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Receive usual care

Computer Application

Intervention Type OTHER

Use computer-based symptom reporting system

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Computer Application

Use computer-based symptom reporting system

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Application application software computer applicaion Quality of Life Assessment

Eligibility Criteria

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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.

Exclusion Criteria

* Inability to provide informed consent.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Maria Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

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Kennedy Health Systems- Cancer Center

Sewell, New Jersey, United States

Site Status

Thomas Jefferson University Hopsital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JT 13449

Identifier Type: OTHER

Identifier Source: secondary_id

R43MD011210

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19F.163

Identifier Type: -

Identifier Source: org_study_id

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