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临床试验/CTRI/2018/05/013603
CTRI/2018/05/013603已完成3 期

Comparative impact of two educational intervention strategies for improving Quality of Life of cervical cancer patients reporting at PGIMER, Chandigarh: A two group RCT

未提供1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年1月6日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
180
试验地点
1
主要终点
Improvement in Quality of life

研究概览

简要总结

Thepresent study was conducted with the following objectives 1- To estimate theextent and pattern of gynaecological cancer patients reporting at PGIMER,Chandigarh. 2- To document the existing system of patient handling andinformation provision to cervical cancer patients and their family care giversreporting at PGIMER, Chandigarh. 3- To ascertain the problems faced by cervicalcancer patients and their family care givers regarding illness, diagnosis andtreatment of cervical cancer. 4- To document the information gap amongst cancercervix patients and their family care givers regarding various aspects ofcervical cancer. 5- To compare the impact of two educational interventionstrategies (Information booklet with and without face to face counselling) onQuality of Life of cervical cancer patients reporting at PGIMER, Chandigarh.

Retrospectivedata from 2012-2016 was collected from hospital records to document the caseload of gynaecological cancer admissions. Further, a Randomized Control Trialwas conductedat the Department of Gynaecology and Department of Radiotherapy of PGIMER,Chandigarh from July 2018 to August 2019. A total of 180 cervical cancerpatients were randomized into two groups viz. Intervention group (Informationbooklet and two face to face counselling sessions) and Control group(information booklet alone). Thepatients recruited for the RCT were also interviewed for problems faced andInformation gap. All patients were followed up twice during a six-monthinterval. Minimum interval between any two visits was one month. EORTC QLQ-C30and EORTC QLQ-CX 24 tools were used to assess the Quality of Life at Baselineand subsequent Follow ups.

An average annual case loadfor gynaecological cancer admissions of 795 was noted for PGIMER, Chandigarhduring the period from 2012 to 2016. Results show that Lossof appetite, fatigue, anxiety and compromised role functioning were most commonadverse effects reported by >80% women undergoing therapy.  Regarding direct care giving, around 80%family caregivers faced problems in scheduling appointments and coordinatingcare. New patients had less information on cancer and its related aspectscompared to Old patients. Patients wished to receive more information diet,self-care and pain management. A significant improvement inQuality of Life of post therapy Intervention group (Group A) patients was seenat second follow up visit on Emotional functioning, Social functioning,Fatigue, Nausea and vomiting, Insomnia, Constipation, Global Health status, Symptomexperience, Body Image, Lymphedema, Peripheral neuropathy, and Menstrualsymptoms compared to Control Group (Group B) patients. Overall, the intervention group patients who received face to facecounselling and booklet reported better Quality of Life on second follow upvisit as compared to Control group patients who received booklet alone.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 85.00 Year(s)(—)
性别
Female

入选标准

  • Patients and caregivers willing to participate.

排除标准

  • Moribund patients.

结局指标

主要结局

Improvement in Quality of life

时间窗: 3 months

次要结局

  • Improvement in awareness level(3 months)

研究者

发起方
未提供

研究点 (1)

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