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Quality of Life Among Testicular Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02304575
Recruitment Status : Unknown
Verified October 2017 by Rabin Medical Center.
Recruitment status was:  Recruiting
First Posted : December 2, 2014
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date November 27, 2014
First Posted Date December 2, 2014
Last Update Posted Date October 17, 2017
Study Start Date January 2015
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2014)
Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire. [ Time Frame: 2-10 years from diagnosis ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 1, 2014)
  • Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index [ Time Frame: 2-10 years from diagnosis ]
  • cognitive orientation score [ Time Frame: 2-10 years from diagnosis ]
  • multidimensional coping score [ Time Frame: 2-10 years from diagnosis ]
  • cognitive function as measured by the meaning test [ Time Frame: 2-10 years from diagnosis ]
  • Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire [ Time Frame: 2-10 years from diagnosis ]
  • Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory [ Time Frame: 2-10 years from diagnosis ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life Among Testicular Cancer Survivors
Official Title Quality of Life Among Testicular Cancer Survivors
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Testicular Neoplasms
  • Spermatic Cord Torsion
  • Varicocele
  • Testicular Hydrocele
Intervention
  • 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.
Study Groups/Cohorts
  • Testicular cancer survivors
    Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement.
    Interventions:
    • Other: Questionnaires
    • Other: Hormonal Function measurement
  • Surgery for benign testicular problems
    Patients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement.
    Interventions:
    • Other: Questionnaires
    • Other: Hormonal Function measurement
  • Healthy males
    Healthy volunteers, will receive questionnaires and hormonal function measurement.
    Interventions:
    • Other: Questionnaires
    • Other: Hormonal Function measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 1, 2014)
330
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02304575
Other Study ID Numbers 0482-14-RMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rabin Medical Center
Study Sponsor Rabin Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: David Margel, MD PhD Rabin MC
PRS Account Rabin Medical Center
Verification Date October 2017