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临床试验/NCT05368116
NCT05368116已完成不适用

Effectiveness of Video Assisted Self Management Program on Chemotherapy Side Effects in Terms of Knowledge, Self Efficacy and Severity of Side Effects Among the Cancer Patient Receiving Chemotherapy at Oncology Day Care

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Severity of Side effects including Nausea, Vomiting, Diarrhea, Constipation, Mucositis, Fever, Pain ,Dry Skin and alopecia related distress.

研究概览

简要总结

A study to assess the effectiveness of video assisted Self Management Program on chemotherapy side effects in terms of Knowledge, Self Efficacy and Severity of side effects among the Cancer patient receiving chemotherapy at Oncology day care ILBS , New Delhi.

Primary Objective:

  1. To assess the Knowledge, Self Efficacy and Severity of side effects of chemotherapy related side effects in the Experiment Vs. Comparison group among the cancer patients receiving chemotherapy.
  2. To compare the knowledge and self efficacy scores in Experimental Vs. Comparison group after video assisted SMP among the cancer patients receiving chemotherapy.
  3. To compare the severity of chemotherapy related side effects in Experiment Vs. Comparison group before and after video assisted SMP among the cancer patients receiving chemotherapy.

Secondary Objective To find the correlation between knowledge and self efficacy scores among the cancer patients receiving chemotherapy under Experimental Group.

  1. To determine the association of Severity of side effects with the knowledge and self efficacy scores among the cancer patients receiving chemotherapy.

  2. To determine the association of knowledge, self efficacy with the socio demographic and clinical variables among the cancer patients receiving chemotherapy.

The study assumes that:

  1. Video assisted teaching is an accepted teaching strategy and enhances teaching learning activities.
  2. Patients may have limited knowledge about the management of side effects related to chemotherapy including nausea, vomiting, diarrhea, Constipation, dry skin, fever, alopecia related distress and pain.
  3. Patients may have decrease severity of chemotherapy related side effects including nausea, vomiting, diarrhea, Constipation , dry skin, fever , alopecia related distress and pain. After the self management program.

详细描述

Effectiveness A measure of the extent to which a specific intervention, procedure, regimen, or service when deployed in the field of routine circumstances, does it intended to do for a specific population. (Wojtezak, 2002) In this study, effectiveness refers to the degree to which the video assisted SMP is successful in the management of chemotherapy related side effects in terms of gain in Knowledge, self efficacy scores and reducing the severity of side effects among the cancer patient receiving chemotherapy.

Video Assisted Self Management Program It referred to an instructional aid which incorporates visual and auditory information on a topic for individual to understand and learn. (MedCrave 2016) In this study it refers to the systematically designed Video Assisted teaching program to educate cancer patients receiving chemotherapy under the experimental group about the management of chemotherapy related side effects at home .It will be one to one teaching session of 10-20 minutes conducted by the principal researcher with the help of a video on self management of chemotherapy related side effects and the video will focus on the self management of selected side effects of chemotherapy including Nausea, vomiting , Diarrhea ,Constipation, Fever , Mucositis , Skin changes , and Alopecia related distress.

Chemotherapy side effects It is the unintended effect occurring at normal dose related to the pharmacological properties. (WHO) In this study it refers to the commonly reported chemotherapy related side effects by the patients receiving chemotherapy including nausea vomiting, Diarrhea, Constipation, Fever, Mucositis, Dry skin, and Alopecia related distress in cancer patients after receiving chemotherapy.

Knowledge It is defined as the familiarity, awareness, or understanding of someone or something such as facts, skills or objects. (Plato) In this study it refers to the correct response of the patient to the questionnaire regarding the self management of the side effects of chemotherapy. It will be assessed by the Structured Questionnaire on self management of chemotherapy related side effects with 20 items. The scores will be analyzed in the form of means.

Cancer Patients Cancer Patient is defined as a person receiving or registered to receive medical treatment in the Hospital for Cancer. (American Cancer Society) In this study it refers to the person either male or female who is suffering from any type of cancer that includes but not limited to Head and Neck, Pancreas, Liver, Gall bladder, Breast, Stomach, and mouth cancer and receiving chemotherapy at Onco day care ILBS, New Delhi at the time of data collection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the cancer patients receiving chemotherapy at Onco day care ILBS which will be included in the study who-
  • Were 18 years or older
  • Patients who have undergone at least one chemotherapy cycle.
  • Patients who are stable.
  • Can Communicate in English / Hindi
  • Patients who are Mentally alert

排除标准

  • All cancer patients undergoing chemotherapy was excluded from the study who -
  • Patients who are Android mobile users Patients with visual and hearing impairments
  • Had hemodynamic instability.

结局指标

主要结局

Severity of Side effects including Nausea, Vomiting, Diarrhea, Constipation, Mucositis, Fever, Pain ,Dry Skin and alopecia related distress.

时间窗: up to 5 weeks

It consists of grades which are used to assess the severity of adverse events. Grades ranges from 0 to 5. The scores assessed by the researcher for the severity of side effects will be verified by the doctors on duty. The Distress thermometer was developed as a simple tool to effectively screen for symptom of Alopecia related distress. It is a self reported tool using a 0-10 rating scale. The scale was explained to all the participants and participants were asked to circle or pick a number 0-10 from the drop down box that best describes how much distress patient have been experiencing in the past weeks including today.

Knowledge regarding the management of chemotherapy related side effects.

时间窗: up to 5 weeks

A structured 20 item knowledge questionnaire developed for assessment of knowledge among the cancer patients receiving chemotherapy at Onco day care Ilbs. The knowledge questionnaire will be self reported by the subjects.

self efficacy in relation to symptom management relevant to chemotherapy for patients with cancer.

时间窗: up to 5 weeks

The Structured Symptom-Management Self-Efficacy Scale derived from - Symptom-Management Self-Efficacy Scale Breast Cancer (SMSES-Breast Ca.) It was developed by SY Liang et al., in 2015 that measure perceived self efficacy in terms of respondent's ability to self manage the symptoms of chemotherapy. It is an 11-point Likert scale was used for each item that ranged from 0 (not confident at all) to 10 (completely confident), with higher scores representing higher perceived self-efficacy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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