Prostate Cancer Survey

November 2, 2020 updated by: Department of Radiation Oncology, University of Maryland, Baltimore

Identifying Patient-relevant Adverse Events Following Prostate Radiotherapy

There have been calls from patients, payers, healthcare providers, and policy makers for an evaluation of newer, high-cost radiation technologies compared to conventional forms of radiation therapy. National attention has focused on the use of intensity modulated radiation therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the present study is to determine whether the type of radiation treatment received by the patients can result in a reduction in patient-relevant side effects following prostate irradiation. The analysis will be performed by obtaining patient answered surveys looking at side effects.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

224

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
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • UMMC

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

Male

Sampling Method

Probability Sample

Study Population

Patients with prostate malignancies who consent to receiving Radiation treatment at the University of Maryland, Baltimore, will be offered this survey.

Description

Inclusion Criteria:

  • Participant is 18 years or older
  • Has been diagnosed with prostate cancer
  • Able to speak and read English

Exclusion Criteria:

  • Participant is not being seen for prostate cancer
  • Under the age of 18

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
Survey Group
Approximately 300 patients with prostate cancer will be provided a survey investigating their treatment preferences and side effects faced during and after receiving radiation treatment.
Focus Group
Approximately 75 participants will participate in a focus group. All participants will have completed radiation treatment and will discuss side effects after having received radiation, as well as their quality of life while receiving radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine patient preference weights for side effect reduction in radiation treatment of prostate cancer
Time Frame: 3 years
Investigators will use an anonymous survey and results from multiple focus groups to quantify the relative importance/significance of commonly encountered side effects experienced by patients following external beam radiation therapy. We will complete descriptive statistics as a means of understanding the data obtained by survey responses. Additionally, comparative analyses may be undertaken to evaluate differences between different side effects experienced.
3 years

Collaborators and Investigators

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

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Mark Mishra, MD, University of Maryland, Baltimore

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 15, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00073268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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