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

NCT01849471 | Unknown

• 1 other identifier: EP2013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

socioeconomic aspects; costs of therapy; follow-up costs; primary radiation; percutaneous; interstitial

Outcome Measures

Primary Outcomes (1)

• therapy concerning and follow-up costs associated with changes in social professional situation that is connected with Quality of life

  by questionnaires concerning social aspects and quality of life to evaluate connections between these parameters

  Participants will be followed for the duration of therapy and for 1 year after the last study treatment

Secondary Outcomes (2)

• adverse events

  Participants will be followed for the duration of therapy and for 1 year after the last study treatment

• correlation of quality of life, adverse events and economic aspects for the patient and the health insurance coverage

  Participants will be followed for the duration of therapy and for 1 year after the last study treatment

Study Arms (1)

patients with prostate cancer

questionnaires

Other: questionnaires

Interventions

questionnaires OTHER

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

patients with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with prostata cancer that receive primary radiation therapy

You may qualify if:

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

You may not qualify if:

• tumor recurrence
• surgery as primary therapy
• prior radiotherapy except conventional radiotherapy
• patients with other malignancies

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Annedore Strnad, MD, MHBA

  Strahlenklinik, Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

• Rainer Fietkau, MD

  Strahlenklinik, Universitätsklinikum Erlangen

  STUDY DIRECTOR

Central Study Contacts

Annedore Strnad, MD, MHBA

CONTACT

++49(0)9131 85; annedore.strnad@uk.erlangen.de

Rainer Fietkau, MD

CONTACT

++49(0)9131 85; st-studiensekretariat@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 8, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 1, 2016

Record last verified: 2016-07

Locations

DE (1)