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临床试验/CTRI/2024/07/070768
CTRI/2024/07/070768尚未招募3 期

Effectiveness of multi-modal interventions on Quality of life, symptom burdens and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata.

Chaitali Biswas1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月1日最近更新:

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

发起方
Chaitali Biswas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Chaitali Biswas

Tata Medical Center

研究点 (1)

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