Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Copenhagen University Hospital at Herlev

ClinicalTrials.gov Identifier:

NCT01441713

First received: September 9, 2011

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2011

Last Updated Date

December 4, 2012

Start Date ^ICMJE

September 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Preferred treatment/control frequency for patients with advanced prostate cancer [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Preferred treatment frequency is assessed by patient answers to the question:

"If treatments were equally effective from a medical standpoint - How often would you then prefer to receive treatment"

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01441713 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment satisfaction [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Treatment satisfaction ranging from "Very satisfied" til "Very unsatisfied" assessed by patient answers to the questionnaire
Side effects to treatment [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Side effects to treatment assessed by patient answers to the questionnaire
Treatment satisfaction, preferred frequency of clinical control, and side effects after surgical castration [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
As a secondary endpoint the investigators will look at answers to satisfaction, wishes for control visits and side effects in the group of patients who received surgical castration for their advanced prostate cancer.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

Official Title ^ICMJE

Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer

Brief Summary

Patients with advanced prostate cancer usually receive some kind of pharmaceutical castration or undergo surgical castration. At the investigators department the pharmaceutical treatment is most often given with a 3 month interval.

Over the last few years new drugs, which allow for lees frequent treatment, have been developed. The purpose of this study is to assess how the treatment affects patients and if our current patients would prefer to receive treatment at different intervals than they do at the present time. At the same time the investigators will assess how surgical treatment affects our patients. This will be assessed by patient questionnaires administered at our clinic.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Men who are receiving pharmaceutical castration treatment (hormone treatment) at Herlev Hospital for advanced prostate cancer and men who have undergone surgical castration (Orchiectomy) and are in clinical control at Herlev Hospital.

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Pharmaceutical group
Patients in pharmaceutical castration treatment for advanced prostate cancer
Surgical group
Patients having undergone surgical castration treatment for advanced prostate cancer

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

178

Completion Date

June 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

A diagnosis of advanced prostate cancer
Receiving hormone manipulation treatment (pharmaceutical castration) OR having undergone surgical castration (orchiectomy)

Exclusion Criteria:

Inability to read/write Danish

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01441713

Other Study ID Numbers ^ICMJE

HeH.750.19-25

Has Data Monitoring Committee

Responsible Party

Copenhagen University Hospital at Herlev

Study Sponsor ^ICMJE

Copenhagen University Hospital at Herlev

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mikkel Fode, MD

Herlev Hospital, University of Copenhagen

Information Provided By

Copenhagen University Hospital at Herlev

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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