Effectiveness of multi-modal interventions on Quality of life, symptom burdens and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate the effect of multi-modal interventions on Quality of life, Symptom management and self-efficacy among ovarian cancer pateints
研究概览
简要总结
This study is a single-center, randomized, parallel-group open trial to assess the effectiveness of multi-modal interventions on quality of life, symptom burdens, and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata. The study aims to prepare & implement multi-modal interventions to determine QOL, symptom burdens & self-efficacy among Ovarian cancer patients. The study will follow an RCT design for 9 months of each patient’s coverage. Multi-modal interventions include four multi-component nursing intervention sessions (Pre-treatment session, Sensitization session, Prehabilitation session, and Symptom management session) through various modes of instruction; each session will be on Four different days within the period of 1 to 21 days. It will be given only to the experimental group of ovarian cancer patients undergoing treatment with surgery or chemotherapy to improve their Quality of life and self-efficacy and to reduce their symptom burdens. Multi-modal interventions will be reinforced and monitored through telephonic conversation and in each follow-up visit at the Outpatient department every three months till six months of the treatment.
Standardized tools will be used to collect data as a baseline & every 3-month intervals after the implementation of the intervention for both groups of participants. The study’s primary objective is to evaluate the effect of multi-modal interventions on quality of life, symptom burdens, and self-efficacy among ovarian cancer patients. The secondary outcome is encouraging and motivating the individual to adapt the intervention daily to improve self-efficacy, self-management, and health-related quality of life. Based on the findings, this can be implemented as routine care for ovarian 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
- 19.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •Newly diagnosed Ovarian cancer patients
- •With any stage from II, III, and IV.
- •Eastern Cooperative Oncology group (ECOG) performance status within
- •Planned for initial treatment either with chemotherapy or Surgery.
- •Able to understand, read, and write Bengali or Hindi or English.
排除标准
- •Ovarian cancer patients who are
- •Critically ill.
- •ECOG performance status more than
- •Diagnosed as a relapse of ovarian cancer patients.
- •under palliative care.
结局指标
主要结局
To evaluate the effect of multi-modal interventions on Quality of life, Symptom management and self-efficacy among ovarian cancer pateints
时间窗: Quality of life, Symptom burdens, and self-efficacy as the outcome of the multi-modal intervention will be assessed at baseline, 3 month, 6 month and 9 month for both experimental arm and control arm
次要结局
- To encourage and motivate the individual Ovarian cancer patients under study to adapt the intervention in their daily life and thus to improve the self-efficacy and self management of symptoms and health related quality of life(at 9 months after the study as well as continue throughout the survival period)
研究者
Chaitali Biswas
Tata Medical Center
