Mental Health of Men Before and After Testicular Cancer Treatment. Danish: "Mænds Mentale Sundhed før og Efter Behandling af testikulær kræft"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Erectile Function
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Men, who cannot talk, read ore write Danish.
- •Men who are not able to give informed consent.
结局指标
主要结局
Change in Erectile Function
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).
Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Cognitive Performance, CANTAB iPad based cognitive performance test.
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Fertility related concerns(The Patients complete the questions at baseline (T1).)
- Change in Well being(9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).)
- Change in Quality of Life(9 months. The patients complete the questionnaire at baseline (T1) and again after 9 months (T2).)