Mental Health of Men Before and After Testicular Cancer Treatment

Cognitive Impairment Clinical Trial

Official title:

Mental Health of Men Before and After Testicular Cancer Treatment. Danish: "Mænds Mentale Sundhed før og Efter Behandling af testikulær kræft"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880994
• Other study ID #: TC_Horsens
• Status: Completed
• Start date: March 25, 2019
• Est. completion date: March 25, 2022

Study information

• Verified date: June 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Sexual Dysfunction
• Testicular Neoplasms
• Testis Cancer

Locations

Country	Name	City	State
Denmark	Horsens fertility Clinic, Region Hospital Horsens	Horsens

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Performance, CANTAB iPad based cognitive performance test.	The cognitive test is performed on an iPad using the validated Cambridge Neuropsychological Test Automated Battery (CANTAB) Connect Research software. The cognitive domains assessed are sensorimotor function and comprehension, processing and psychomotor speed, sustained attention, visual episodic memory, working memory and strategy, visual working memory and planning, each at T1 and T2. Comparison of test results from T1 and T2 will assess if there is a change in the cognitive performance.	9 months. The patients complete the cognitive test at baseline (T1) and again after 9 months (T2).
Primary	Change in Self reported Cognitive Performance	Assessed by The Patients Assessment of Own Functioning Inventory (PAOFI)	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Primary	Change in Sexual Health	Assessed by the EORTC Sexual Health Questionnaire (EORTC SHQ-C22)	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Primary	Change in Erectile Function	Assessed by The International Index of Erectile Function (IIEF-5)	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Primary	Change in symptoms of Depression and Anxiety	Assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item scale with 2 subscales measuring severity of anxiety (HADS-A) and depression (HADS-D) symptoms. Each subscale has 7 items and each item is scored from 0-3. Thus, the total score for each subscale range from 0-21, with 0 indicating no symptoms and 21 severe symptoms.	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Primary	Change in Fatigue	Assessed by the FACIT_Fatigue Questionnaire. The questionnaire consists of 13-items each scored from 0-4. The scores are summarized, and the total score range from 0-52 with higher score denoting less fatigue.	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Primary	Change in Sleep Quality	Assessed by the Pittsburgh Sleep Quality Index (PSQI)	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Secondary	Change in Quality of Life	The quality of life is assessed by a subscale from the WHO Quality of Life (WHOQOL)-BREF questionnaire. The subscale has 2 questions each scored from 1-5. Thus, the total score for this subscale range from 2-10 with higher scores denoting higher quality of life.	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Secondary	Change in Well being	The wellbeing is assessed by the WHO (Five) Well-being scale (WHO-5), that has 5 questions each scored from 0-5. The raw score ranges from 0-25 and is multiplied by 4 to give the final score that ranges from 0-100, with higher scores denoting higher wellbeing.	9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Secondary	Fertility related concerns	The patient answers 5 questions regarding fertility related concerns, investigating if he has concerns about being able to become a father with or without fertility assistance. Also, the patient answers 4 questions regarding the information given by healthcare professionals, to assess if he finds, that he has been given enough information regarding semen deposit and possible later fertility assistance.; None of these 9 questions are validated.	The Patients complete the questions at baseline (T1).