Quality of Life Among Testicular Cancer Survivors

October 15, 2017 updated by: Rabin Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David Margel, MD PhD
  • Phone Number: +972(0)39378089

Study Contact Backup

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center, Beilinson & Hasharon Hospitals
        • Contact:
          • David Margel, MD PhD
          • Phone Number: +972(0)39378089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index
Time Frame: 2-10 years from diagnosis
2-10 years from diagnosis
cognitive orientation score
Time Frame: 2-10 years from diagnosis
2-10 years from diagnosis
multidimensional coping score
Time Frame: 2-10 years from diagnosis
2-10 years from diagnosis
cognitive function as measured by the meaning test
Time Frame: 2-10 years from diagnosis
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
2-10 years from diagnosis
Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory
Time Frame: 2-10 years from diagnosis
2-10 years from diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: David Margel, MD PhD, Rabin MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 15, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0482-14-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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