Clinical trial NCT02304575: Quality of Life Among Testicular Cancer Survivors
Official title: Quality of Life Among Testicular Cancer Survivors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Testicular Neoplasms
Spermatic Cord Torsion
Varicocele
Testicular Hydrocele
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 330
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
timeFrame: 2-10 years from diagnosis
Secondary outcomes:
measure: Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index
timeFrame: 2-10 years from diagnosis
measure: cognitive orientation score
timeFrame: 2-10 years from diagnosis
measure: multidimensional coping score
timeFrame: 2-10 years from diagnosis
measure: cognitive function as measured by the meaning test
timeFrame: 2-10 years from diagnosis
measure: Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire
timeFrame: 2-10 years from diagnosis
measure: Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory
timeFrame: 2-10 years from diagnosis
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson & Hasharon Hospitals
Study officials:
affiliation: Rabin MC
name: David Margel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: