Effect of a Psycho-educational Intervention on Psychological Outcomes and Quality of Life Among Gynecological Cancer Patients in El-shatby University Hospital, Alexandria: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- A change in the Quality of life of gynecological cancer patients
研究概览
简要总结
This study will be conducted to optimize the quality of care rendered for gynecological cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in Alexandria.As well as to assess the effect of implementing a psychoeducational intervention program among gynecological cancer women on the:
- Quality of life with its different domains (physical, emotional, social and functional). "as a primary objective"
- Psychological distress and cancer-specific stress. "as secondary objectives"
详细描述
Cancer is a significant health problem worldwide with wide geographical variation in incidence. Additionally it has become an important item in each country's health agenda.It is a prominent cause of mortality in both economically developed and underdeveloped nations.Unfortunately, the burden is expected to grow globally due to the development and aging of the population.Gynecological cancer, which includes cancers of the cervix, ovary, uterus, vulva, vagina and fallopian tube are among the leading causes of cancer-related mortality worldwide.In Egypt, according to the Global Cancer Observatory (GLOBOCAN) 2020, approximately 2,787 new cases for ovarian cancer were diagnosed and 1,839 women died from the disease,1,694 new cases for uterine cancer and 350 women died from the disease and 1,320 new cases for cervical cancer and 744 women died from the disease.
Hence, this study will be carried out to develop and implement a psychoeducational intervention program among gynecological cancer patients attending the Gynecological Oncology Unit in El-Shatby University Hospital in Alexandria and evaluate its effect in improving their psychological outcomes and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women are eligible to participate if they are:
- •Over 20 years old.
- •Newly diagnosed cases with gynecological cancers (confirmed within 3 months).
- •Scheduled to have surgery as the first-line treatment.
- •Willing to participate in the study.
排除标准
- •Women are excluded if they:
- •Are in the late stage (stage IV) as women in this group usually receive palliative/ symptomatic treatment.
- •Have additional cancer diagnosis (including metastasis).
- •Are diagnosed with severe psychiatric or cognitive disorder.
- •Participate in other intervention study.
结局指标
主要结局
A change in the Quality of life of gynecological cancer patients
时间窗: over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation
A change in the Quality of life from baseline and follow up sessions is assessed using the Arabic version of the Functional Assessment of Cancer Therapy-General (FACT-G) version 4. It includes 27 items and covers four primary QOL domains: physical wellbeing (PWB; 7 items, score range 0-28), emotional well-being (EWB; 6 items, score range 0-24), social well-being (SWB; 7 items, score range 0-28) and functional well-being (FWB; 7 items, score range 0-28). A five-point Likert scale will be used (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much), which provided four subscale scores and a total score ranging from 0 to 108, a higher score meaning a poor QOL, a lower score indicating high QOL and low effect of gynecological cancer treatment on QOL.
次要结局
- A change in the Anxiety and depression(over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation)
- A change in the Cancer-specific stress(over approximately 2 months for each patient as the tool is used initially before surgery and reused 8 weeks after the operation)