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Completed

NCT Number: NCT03880994

Mental Health of Men Before and After Testicular Cancer Treatment

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).

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Key information

Conditions

Testis Cancer Anxiety Disorders Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Depression Dyssomnias Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Horsens fertility Clinic, Region Hospital Horsens

Horsens, 8700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cognitive Performance, CANTAB iPad based cognitive performance test.

    Time frame: 9 months. The patients complete the cognitive test at baseline (T1) and again after 9 months (T2).

    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.

  2. Change in Self reported Cognitive Performance

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    Assessed by The Patients Assessment of Own Functioning Inventory (PAOFI)

  3. Change in Sexual Health

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    Assessed by the EORTC Sexual Health Questionnaire (EORTC SHQ-C22)

  4. Change in Erectile Function

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    Assessed by The International Index of Erectile Function (IIEF-5)

  5. Change in symptoms of Depression and Anxiety

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    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.

  6. Change in Fatigue

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    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.

  7. Change in Sleep Quality

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    Assessed by the Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

  1. Change in Quality of Life

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    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.

  2. Change in Well being

    Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).

    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.

  3. Fertility related concerns

    Time frame: The Patients complete the questions at baseline (T1).

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2019
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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