Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02304575
Status:
UNKNOWN
Last Update Posted:
2017-10-17
First Post:
2014-11-27
Brief Title:
Quality of Life Among Testicular Cancer Survivors
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Quality of Life Among Testicular Cancer Survivors
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age with incidence rates rising in western countries including Israel Cure rate of testicular cancer exceeds 90 with modern treatments Thus issues such as quality of life QoL coping effects on couple relationships cognitive function cognitive orientation and hormonal function become increasingly important This study aims to assess all these issues using validated reproducible questionnaires and hormonal plasma levels and compare them between testicular cancer survivors and controls
Detailed Description:
The study will be conducted in RMC Beilinson and Golda Eligible male patient list will be drawn from the Rabin Medical Center RMC operation rooms data system
Patients will be contacted by their treating urologists over the phone or during follow-up visits and invited to take part in the research which will be conducted at RMC The first stage of the study will include a validation of the EORTC QLQ-TC26 questionnaire in Hebrew
Patients and partners spouses will sign informed-consent forms and fill out questionnaires during their visit and blood samples will be drawn on the day of questionnaire completion or no longer than 1 month from it Spouses will be given the choice of arriving with the patient and filling-in their questionnaires at RMC or having them mailed to their homes Research assistants will provide assistance with the questionnaires
Normal controls will be recruited among Tel Aviv University students Achva College students and RMS staff and asked to come to RMC for blood tests Control subjects will be asked to answer the same cancer-related questionnaires as the patients as fully as possible unless the questions are irrelevant to them
The anticipated recruitment period will be approximately 36 months Financial incentives a compensation of 150 NIS will be offered to healthy participants coming to RMC for blood tests under this study
Duration of research participation 1 or 2 encounters the second for missing data or missing blood samples and in the first 30 patients - for TC26 questionnaire re-validation by the EORTC requirements during no longer than 1 month for each participant
Measurements will be compared across the patient and 2 control groups and their correlation to hormonal function assessed
Patients will be contacted by their treating urologists over the phone or during follow-up visits and invited to take part in the research which will be conducted at RMC The first stage of the study will include a validation of the EORTC QLQ-TC26 questionnaire in Hebrew
Patients and partners spouses will sign informed-consent forms and fill out questionnaires during their visit and blood samples will be drawn on the day of questionnaire completion or no longer than 1 month from it Spouses will be given the choice of arriving with the patient and filling-in their questionnaires at RMC or having them mailed to their homes Research assistants will provide assistance with the questionnaires
Normal controls will be recruited among Tel Aviv University students Achva College students and RMS staff and asked to come to RMC for blood tests Control subjects will be asked to answer the same cancer-related questionnaires as the patients as fully as possible unless the questions are irrelevant to them
The anticipated recruitment period will be approximately 36 months Financial incentives a compensation of 150 NIS will be offered to healthy participants coming to RMC for blood tests under this study
Duration of research participation 1 or 2 encounters the second for missing data or missing blood samples and in the first 30 patients - for TC26 questionnaire re-validation by the EORTC requirements during no longer than 1 month for each participant
Measurements will be compared across the patient and 2 control groups and their correlation to hormonal function assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None