Socioeconomic Aspects Before and After Radiation Therapy in Patient With Prostate Cancer

NCT ID: NCT01849471

Last Updated: 2016-08-01

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is an interrogation of patients with prostate cancer to evaluate socioeconomic effects of radiotherapy. Patients with percutaneous or interstitial or combined percutaneous and interstitial radiotherapy are included. Beside medical effects and adverse events, it's prospectively needed to extensively inform patients about socioeconomic aspects associated with radiotherapy. The interrogation comprises to collect possible costs and expenditures during and after therapy. Aspects especially concerning post therapy period include additional consultations, individual applied alternative medical care, need for additional medical aids (salves, medicine, bandages) and changes in professional and social situation. It's figured out in what extend costs are absorbed by health insurance coverage. In Germany there is no appropriate trial with respective patient population and respective therapy. Primary endpoint is the evaluation of therapy concerning and follow-up costs as well as changes in social and professional situation. Secondary endpoints are quality of life, adverse events of therapy and the correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with prostate cancer

questionnaires

questionnaires

Intervention Type OTHER

patients receive questionnaires regarding socioeconomic aspects before, during and after therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaires

patients receive questionnaires regarding socioeconomic aspects before, during and after therapy

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* minimal age 18
* low, mediate and high-grade prostate cancer

Exclusion Criteria

* tumor recurrence
* surgery as primary therapy
* prior radiotherapy except conventional radiotherapy
* patients with other malignancies
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Annedore Strnad, MD, MHBA

Role: PRINCIPAL_INVESTIGATOR

Strahlenklinik, Universitätsklinikum Erlangen

Rainer Fietkau, MD

Role: STUDY_DIRECTOR

Strahlenklinik, Universitätsklinikum Erlangen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Annedore Strnad, MD, MHBA

Role: CONTACT

++49(0)9131 85 ext. 33968

Rainer Fietkau, MD

Role: CONTACT

++49(0)9131 85 ext. 33968

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Annedore Strnad, MD, MHBA

Role: primary

++49(0) 9131 85 ext. 33968

Rainer Fietkau, MD

Role: backup

++49(0) 9131 85 ext. 33968

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EP2013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prostate Cancer Survey
NCT03128710 COMPLETED
Characterization of Prostate Cancer With 3T MR
NCT00831142 ACTIVE_NOT_RECRUITING