Impact of CALM therapy:Advanced Cancer and Living Meaningfully-a psychological intervention in advanced gynecological cancers.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To assess the impact of CALM therapy intervention on depression and on anxiety in advanced gynecological cancer patients.
研究概览
简要总结
Depression and anxiety is a very common in advanced gynecological cancer patients.CALM therapy is an acronym for Advanced Cancer and Living meaningfully.CALM therapy is a validated therapy to improve the quality of life in cancer patient.Many trials have been conducted assessing the effectiveness of CALM therapy.Advanced stage gynecological cancer patients will be recruited and randomised into case and control.Baseline assessment of deprerssion and anxiety and their current quality of life will be assessed by validated psychological questionarres like GAD 7,PHQ 9 and QUAL -EC.CALM therapy will be given to patients in case group -minimum 3-6 sessions will be given.Reassessment will be done at the end of 3 months and 6 months for all patients in control and case group and effectiveness of CALM therapy over depression,anxiety and quality of life of cancer patients will be assessed.CALM therapy is already studied by Rickinder sethi et al.,Gary Rodin et al.,Christopher lo et al.,and many others.In all these studies there was no adverse effect documented and found to be beneficial in cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Advanced gynecological cancer patients without any previous history of pshychological disorders and who are influenced in Malayalam and English.
排除标准
- •Early stage gynecological cancer patients and not influent in english and malayalam and not consenting for the study.
结局指标
主要结局
To assess the impact of CALM therapy intervention on depression and on anxiety in advanced gynecological cancer patients.
时间窗: Baseline assessment of depression and anxiety in advanced gynecological cancer patients at the time of diagnosis before providing any intervention and at the end of 3 months and 6 months
次要结局
- To calculate the incidence of depression and on anxiety in advanced gynecological cancer patients and to assess the impact of CALM therapy intervention on quality of life in cancer patients and to evaluate the effectiveness of CALM therapy and to assess the possibility of executing CALM therapy as a usual routine care in our institute(Baseline assessment of depression and anxiety in advanced gynecological cancer patients at the time of diagnosis before providing any intervention and at the end of 3 months and 6 months)
研究者
Dr Deepika Rajkumar
Amrita Institute of medical science,Amrita Vishwa vidhyapeetham