Mental Health of Men Before and After Testicular Cancer Treatment

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT03880994

Collaborator

(none)

Enrollment

Location

35.2

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Testis Cancer Cognitive Impairment Sexual Dysfunction

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Mar 25, 2019

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Outcome Measures

Primary Outcome Measures

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

Change in Quality of Life [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.
Change in Well being [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.
Fertility related concerns [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.