Quality of Life Among Testicular Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
研究概览
简要总结
Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age, with incidence rates rising in western countries including Israel. Cure rate of testicular cancer exceeds 90% with modern treatments. Thus issues such as quality of life (QoL), coping, effects on couple relationships, cognitive function, cognitive orientation and hormonal function become increasingly important. This study aims to assess all these issues using validated, reproducible questionnaires and hormonal plasma levels, and compare them between testicular cancer survivors and controls.
详细描述
The study will be conducted in RMC, Beilinson and Golda. Eligible male patient list will be drawn from the Rabin Medical Center (RMC) operation rooms' data system.
Patients will be contacted by their treating urologists over the phone or during follow-up visits and invited to take part in the research which will be conducted at RMC. The first stage of the study will include a validation of the EORTC QLQ-TC26 questionnaire in Hebrew.
Patients and partners / spouses will sign informed-consent forms and fill out questionnaires during their visit, and blood samples will be drawn on the day of questionnaire completion or no longer than 1 month from it. Spouses will be given the choice of arriving with the patient and filling-in their questionnaires at RMC, or having them mailed to their homes. Research assistants will provide assistance with the questionnaires.
Normal controls will be recruited among Tel Aviv University students, 'Achva' College students and RMS staff and asked to come to RMC for blood tests. Control subjects will be asked to answer the same cancer-related questionnaires as the patients, as fully as possible, unless the questions are irrelevant to them.
The anticipated recruitment period will be approximately 36 months. Financial incentives: a compensation of 150 NIS will be offered to healthy participants coming to RMC for blood tests under this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Group1: Testicular cancer long-term survivors
- •Male subjects between 2 to 10 years after testicular cancer diagnosis, who have completed treatment and are regarded as complete responders.
- •Able to give informed consent Group 2: Benign testicular conditions patients
- •Male subjects between 2 to 10 years after testicular surgery due to a benign condition.
- •Able to give informed consent Group 3: Healthy Controls
- •Healthy males
- •Able to give informed consent Partners of males from above 3 groups
- •Females or males
- •In a couple relationship with a man of 1 of the above groups, for 1 year or longer.
- •Able to give informed consent
- •Exclusion criteria:
- •Group1: Testicular cancer long-term survivors
- •Inability to answer questionnaires (i.e due to mental impairment).
- •Another malignancy, other than non-invasive skin basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- •Testicular cancer recurrence. Group 2: Benign testicular conditions patients
- •Inability to answer questionnaires.
- •Any history of malignancy other than non-invasive skin BCC or SCC. Group 3: Healthy Controls
- •Inability to answer questionnaires.
- •Any history of malignancy other than non-invasive skin BCC or SCC.
- •Any history of testicular surgery or diagnosed testicular problems in adulthood or childhood.
- •Partners of males from above 3 groups
- •Inability to answer questionnaires.
排除标准
- 未提供
结局指标
主要结局
Quality of life (QLQ), as measured by the QLQ-TC26 (Testicular Cancer 26 items) questionnaire.
时间窗: 2-10 years from diagnosis
次要结局
- Partner's Coping mechanism score, as measured by the Multidimensional Coping Inventory(2-10 years from diagnosis)
- Partner's Quality of life, as measured by the multidimensional inventory of QOL for adults questionnaire(2-10 years from diagnosis)
- Hormonal function, as measured by follicular stimulating hormone (FSH) & free androgen index(2-10 years from diagnosis)
- cognitive orientation score(2-10 years from diagnosis)
- cognitive function as measured by the meaning test(2-10 years from diagnosis)
- multidimensional coping score(2-10 years from diagnosis)