Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
330 participants
OBSERVATIONAL
2015-01-31
2018-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Testicular cancer survivors
Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement.
Questionnaires
Questionnaires:
For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires.
For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory.
Hormonal Function measurement
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
Surgery for benign testicular problems
Patients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement.
Questionnaires
Questionnaires:
For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires.
For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory.
Hormonal Function measurement
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
Healthy males
Healthy volunteers, will receive questionnaires and hormonal function measurement.
Questionnaires
Questionnaires:
For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires.
For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory.
Hormonal Function measurement
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
Interventions
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Questionnaires
Questionnaires:
For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires.
For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory.
Hormonal Function measurement
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
Eligibility Criteria
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Inclusion Criteria
* Male subjects between 2 to 10 years after testicular cancer diagnosis, who have completed treatment and are regarded as complete responders.
* Able to give informed consent Group 2: Benign testicular conditions patients
* Male subjects between 2 to 10 years after testicular surgery due to a benign condition.
* Able to give informed consent Group 3: Healthy Controls
* Healthy males
* Able to give informed consent Partners of males from above 3 groups
* Females or males
* In a couple relationship with a man of 1 of the above groups, for 1 year or longer.
* Able to give informed consent
Exclusion Criteria
* Inability to answer questionnaires (i.e due to mental impairment).
* Another malignancy, other than non-invasive skin basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
* Testicular cancer recurrence. Group 2: Benign testicular conditions patients
* Inability to answer questionnaires.
* Any history of malignancy other than non-invasive skin BCC or SCC. Group 3: Healthy Controls
* Inability to answer questionnaires.
* Any history of malignancy other than non-invasive skin BCC or SCC.
* Any history of testicular surgery or diagnosed testicular problems in adulthood or childhood.
Partners of males from above 3 groups
\- Inability to answer questionnaires.
18 Years
75 Years
MALE
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Margel, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Rabin MC
Locations
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Rabin Medical Center, Beilinson & Hasharon Hospitals
Petah Tikva, , Israel
Countries
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Central Contacts
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David Margel, MD PhD
Role: CONTACT
Phone: +972(0)39378089
Facility Contacts
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David Margel, MD PhD
Role: primary
Other Identifiers
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0482-14-RMC
Identifier Type: -
Identifier Source: org_study_id