Clinical trial NCT01849471: Socioeconomic Aspects Before and After Radiation Therapy in Patient With Prostate Cancer
Official title: Evaluation of Socioeconomic Aspects Before and After Primary Radiation Therapy (Percutaneous or Interstitial or Combined Percutaneous and Interstitial) in Patients With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: socioeconomic aspects
costs of therapy
follow-up costs
primary radiation
percutaneous
interstitial
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with prostata cancer that receive primary radiation therapy

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life
timeFrame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
Secondary outcomes:
measure: adverse events
timeFrame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
measure: correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage
timeFrame: Participants will be followed for the duration of therapy and for 1 year after the last study treatment
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
Study officials:
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Annedore Strnad, MD, MHBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Rainer Fietkau, MD
role: STUDY_DIRECTOR
References: