Clinical trial NCT03880994: Mental Health of Men Before and After Testicular Cancer Treatment
Official title: Mental Health of Men Before and After Testicular Cancer Treatment. Danish: "Mænds Mentale Sundhed før og Efter Behandling af testikulær kræft"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testis Cancer
Cognitive Impairment
Sexual Dysfunction
Keywords: Sexual Health
Fatigue
Quality of Life
Depression
Anxiety
Fertility concerns
Sleep Quality
Erectile Function
Cognitive Impairment
Testis Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men aged 18 - 45 years, with newly diagnosed testicular cancer referred to the fertility clinic in Horsens, Denmark, fore cryopreservation of semen prior to further treatment.

Brief summary: This is a prospective observational study, that investigates men diagnosed with testicular cancer before and after treatment.

The patients are included at their visit at the Fertility clinic in Horsens, where they deposit semen for cryopreservation prior to surgery and potential systemic treatment. Here the patients, who want to participate will perform a cognitive test and afterwards complete a questioner (T1). After 9 month the patients will be invited to perform the cognitive test and complete the questionnaire again (T2).


Eligibility criteria: Inclusion Criteria:

* Men aged 18 - 45 years.
* Newly diagnosed testicular cancer and referred to the fertility clinic in Horsens fore cryopreservation of semen prior to further treatment.

Exclusion Criteria:

* Men, who cannot talk, read ore write Danish.
* Men who are not able to give informed consent.

Primary outcomes:
measure: Cognitive Performance, CANTAB iPad based cognitive performance test.
timeFrame: 9 months. The patients complete the cognitive test at baseline (T1) and again after 9 months (T2).
measure: Change in Self reported Cognitive Performance
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Change in Sexual Health
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Change in Erectile Function
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Change in symptoms of Depression and Anxiety
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Change in Fatigue
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Change in Sleep Quality
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Change in Well being
timeFrame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
measure: Fertility related concerns
timeFrame: The Patients complete the questions at baseline (T1).
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens fertility Clinic, Region Hospital Horsens
Study officials:
References: