NCT03128710

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

April 19, 2017

Last Update Submit

November 1, 2024

Conditions

Keywords

SurveyFocus GroupTreatment Preferences

Outcome Measures

Primary Outcomes (1)

  • To determine patient preference weights for side effect reduction in radiation treatment of prostate cancer

    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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMMC

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mark Mishra, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 25, 2017

Study Start

March 15, 2017

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations