Mental Health of Men Before and After Testicular Cancer Treatment

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Sexual Dysfunction; Testis Cancer

• Study Type: Observational
• Enrollment (Anticipated): 28

Contacts and Locations

• Study Contact: Name: Niels Fog Højris, stud.med; Phone Number: 0045 27638031; Email: niel2306@gmail.com
• Study Contact Backup: Name: Ulla Breth Knudsen, Professor; Email: ullaknud@rm.dk

Study Locations

• Denmark
  • Horsens, Denmark, 8700
    • Recruiting
    • Horsens fertility Clinic, Region Hospital Horsens
    • Contact: Niels Fog Højris, Stud.med; Phone Number: 27638031; Email: niel2306@gmail.com
    • Contact: Ulla Breth Knudsen, Professor, Phd; Email: Ullaknud@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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).
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 25, 2019
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Anxiety; Fatigue; Cognitive Impairment; Sleep Quality; Sexual Health; Testis Cancer; Erectile Function; Fertility concerns
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Cognition Disorders; Testicular Neoplasms; Cognitive Dysfunction
• Other Study ID Numbers: TC_Horsens

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No