Testis CancerNCT03880994
Mental Health of Men Before and After Testicular Cancer Treatment
An observational study of Testis Cancer and Cognitive Impairment, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Testis Cancer, Cognitive Impairment, Sexual Dysfunction
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Mar 2019to 25 Mar 2022
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Men, who cannot talk, read ore write Danish.
- Men who are not able to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- 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
- Medical subject headings
- Testicular Neoplasms, Cognitive Dysfunction, Sexual Dysfunction, Physiological, Fatigue, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: The Patients complete the questions at baseline (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start25 Mar 2019
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testis CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880994
- Sponsor's protocol ID
- TC_Horsens
- Status last verified
- Jun 2022
- First submitted
- 12 Mar 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hojris NF, Frederiksen Y, Agerbaek M, Nielsen SH, Holt M, Brand SL, Petersen NL, Knudsen UB, Amidi A. Longitudinal assessment of cognitive function in testicular cancer patients prior to orchiectomy and 9 months later and associations with tumor markers. Support Care Cancer. 2025 Jun 17;33(7):591. doi: 10.1007/s00520-025-09637-w.
PubMed 40526183
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health of Men Before and After Testicular Cancer Treatment. Danish: "Mænds Mentale Sundhed før og Efter Behandling af testikulær kræft"
- ClinicalTrials.gov ID
- NCT03880994
- Acronym / sponsor ID
- TC_Horsens
- Conditions
- Testis Cancer, Cognitive Impairment, Sexual Dysfunction
- Keywords
- Sexual Health, Fatigue, Quality of Life, Depression, Anxiety, Fertility concerns, Sleep Quality, Erectile Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Men, who cannot talk, read ore write Danish.
- Men who are not able to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
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)
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)
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.
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.
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)
3 secondary outcomes
Change in Quality of Life
Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Change in Well being
Time frame: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Fertility related concerns
Time frame: The Patients complete the questions at baseline (T1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 40526183Hojris NF, Frederiksen Y, Agerbaek M, Nielsen SH, Holt M, Brand SL, Petersen NL, Knudsen UB, Amidi A. Longitudinal assessment of cognitive function in testicular cancer patients prior to orchiectomy and 9 months later and associations with tumor markers. Support Care Cancer. 2025 Jun 17;33(7):591. doi: 10.1007/s00520-025-09637-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testis Cancer and Cognitive Impairment, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.