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Mental Health of Men Before and After Testicular Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03880994
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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).


Condition or disease
Testis Cancer Cognitive Impairment Sexual Dysfunction

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Mental Health of Men Before and After Testicular Cancer Treatment. Danish: "Mænds Mentale Sundhed før og Efter Behandling af testikulær kræft"
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880994


Contacts
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Contact: Niels Fog Højris, stud.med 0045 27638031 niel2306@gmail.com
Contact: Ulla Breth Knudsen, Professor ullaknud@rm.dk

Locations
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Denmark
Horsens fertility Clinic, Region Hospital Horsens Recruiting
Horsens, Denmark, 8700
Contact: Niels Fog Højris, Stud.med    27638031    niel2306@gmail.com   
Contact: Ulla Breth Knudsen, Professor, Phd       Ullaknud@rm.dk   
Sponsors and Collaborators
University of Aarhus

Additional Information:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03880994     History of Changes
Other Study ID Numbers: TC_Horsens
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Sexual Health
Fatigue
Quality of Life
Depression
Anxiety
Fertility concerns
Sleep Quality
Erectile Function
Cognitive Impairment
Testis Cancer

Additional relevant MeSH terms:
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Cognitive Dysfunction
Testicular Neoplasms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders