Mental Health of Men Before and After Testicular Cancer Treatment

NCT03880994 | Completed DMC

• 1 other identifier: TC_Horsens
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Change in Quality of Life

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

• Change in Well being

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

• Fertility related concerns

  The Patients complete the questions at baseline (T1).

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Men, who cannot talk, read ore write Danish.
• Men who are not able to give informed consent.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Horsens fertility Clinic, Region Hospital Horsens

Horsens, 8700, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40526183 DERIVED

MeSH Terms

Conditions

Testicular Neoplasms; Cognitive Dysfunction; Sexual Dysfunction, Physiological; Fatigue; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 19, 2019
• Study Start: March 25, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: May 16, 2024

Record last verified: 2022-06

Locations

DK (1)