Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology

June 4, 2021 updated by: Abramson Cancer Center of the University of Pennsylvania
The goals of this study are to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform and to explore the correlation between patient reported outcomes as well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.

Description

Inclusion Criteria:

  • Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.
  • Must be ≥ 18 years of age
  • Able to read, write, and speak English in order to complete patient reported outcomes.

Patients will be approached about the study at the time of consultation or at the time of simulation by their treating physicians or by a research coordinator. All patients must sign a study-specific informed consent to participate. All patients, including those who do not choose to consent to the study, will be provided with a short survey to assess health literacy using the eHealth Literacy Scale (eHEALS).

For those not consenting to the study, the survey will be de-identified and will also ask for basic demographic information including age grouping, race, education level, and type of cancer.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Completed subjects
Subjects will complete patient-reported outcomes assessments during and after radiation therapy.
Other: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Surveys completed
Time Frame: five years
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Lilie Lin, MD, Abramson Cancer Center of the University of Pennsylvania

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

April 1, 2016

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 24915

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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