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Quality of Life Among Testicular Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02304575
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

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.

Condition or disease Intervention/treatment
Testicular Neoplasms Spermatic Cord Torsion Varicocele Testicular Hydrocele Other: Questionnaires Other: Hormonal Function measurement

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.


Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Quality of Life Among Testicular Cancer Survivors
Study Start Date : January 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Testicular cancer survivors
Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement.
Other: 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.


Other: 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.
Other: 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.


Other: 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.
Other: 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.


Other: Hormonal Function measurement
Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.




Primary Outcome Measures :
  1. Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire. [ Time Frame: 2-10 years from diagnosis ]

Secondary Outcome Measures :
  1. Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index [ Time Frame: 2-10 years from diagnosis ]
  2. cognitive orientation score [ Time Frame: 2-10 years from diagnosis ]
  3. multidimensional coping score [ Time Frame: 2-10 years from diagnosis ]
  4. cognitive function as measured by the meaning test [ Time Frame: 2-10 years from diagnosis ]
  5. Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire [ Time Frame: 2-10 years from diagnosis ]
  6. Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory [ Time Frame: 2-10 years from diagnosis ]


Information from the National Library of Medicine

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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
Group1: Testicular cancer long-term survivors Group 2: Benign testicular conditions patients Group 3: Healthy Controls Partners of males from above 3 groups
Criteria

Inclusion Criteria:

Group1: Testicular cancer long-term survivors

  • 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:

Group1: Testicular cancer long-term survivors

  • 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.


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): NCT02304575


Contacts
Contact: David Margel, MD PhD +972(0)39378089
Contact: Chen G Shenhar, MD +972(0)546301847 g.shenhar@gmail.com

Locations
Israel
Rabin Medical Center, Beilinson & Hasharon Hospitals Recruiting
Petah Tikva, Israel
Contact: David Margel, MD PhD    +972(0)39378089      
Principal Investigator: David Margel, MD Phd         
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: David Margel, MD PhD Rabin MC

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02304575     History of Changes
Other Study ID Numbers: 0482-14-RMC
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Testicular Neoplasms
Varicocele
Testicular Hydrocele
Spermatic Cord Torsion
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Vascular Diseases
Cardiovascular Diseases