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Trial record 8 of 1190 for:    Recruiting, Not yet recruiting Studies | QoL

Quality of Life and Sexuality in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02961686
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:
The trial is to describe quality of life in patients affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation.

Condition or disease Intervention/treatment
Quality of Life Radiation: Patients affected by prostate cancer

Detailed Description:
This trial is to describe quality of life and sexuality in patients with prostate cancer treated with exclusive radiotherapy. Descriptive analysis of baseline characteristics will be performed by using appropriate summary measures for continous and categorical data. Analysis of variation over time of FACT scores will be conducted by means of ANOVA analysis for repeated measures.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Sexuality in Patients Treated With Radical Radiotherapy for Prostate Cancer
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Patients with prostate cancer
Patients affected by prostate cancer and treated with a multidisciplinary approach that comprise exclusive radiotherapy, psychological and andrologic evaluation.
Radiation: Patients affected by prostate cancer
Patients affected by prostate cancer and treated with a multidisciplinary approach: it includes exclusive radiotherapy, psychological and andrologic evaluation.




Primary Outcome Measures :
  1. Quality of life measurement [ Time Frame: 2.5 years ]
    Evaluation of the quality of life with FACT-P test in patient affected by prostate cancer treated with exclusive radiotherapy and submitted to psychological and andrologic evaluation



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by prostate cancer
Criteria

Inclusion Criteria:

  • Age 18-75 years.
  • Histologically-proven of prostate cancer
  • Indication to radical radiotherapy on prostate/ prostate + seminal vesicles / prostate + seminal vesicles + pelvic lymph nodes
  • Informed consent

Exclusion Criteria:

  • Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial.
  • Previous surgery for prostate cancer, severe cardiac or vascular pathology
  • Other major surgery in the preceding year or currently undergoing psychiatric care or psychological counseling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961686


Contacts
Contact: Ciro Franzese, MD +390282247454 ciro.franzese@cancercenter.humanitas.it

Locations
Italy
Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Ciro Franzese, MD    +390282247454    ciro.franzese@cancercenter.humanitas.it   
Principal Investigator: Ciro Franzese, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Ciro Franzese Istituto Clinico Humanitas

Responsible Party: Michele Tedeschi, Medical Doctor, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02961686     History of Changes
Other Study ID Numbers: 1635
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases