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临床试验/NCT07457112
NCT07457112已完成不适用

A Controlled Evaluation of EHealth Interventions for Self-Management and Psychological Coping in Cancer Patients

Zagazig University1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2023年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
1
主要终点
Change in Symptom-Management Self-Efficacy Score

研究概览

简要总结

Brief Summary This study evaluates the effectiveness of a structured eHealth-based educational and support intervention in improving self-management practices and psychological coping behaviors among adult cancer patients. Using a quasi-experimental pretest-posttest design with study and control groups, the intervention integrates online education, interactive sessions, and digital communication platforms to enhance symptom management, emotional regulation, and adaptive coping strategies. The findings aim to inform scalable digital health solutions in oncology care.

详细描述

Cancer patients often experience complex physical and psychological challenges related to disease progression and treatment side effects. eHealth interventions offer accessible, personalized, and cost-effective tools that support patient engagement, self-efficacy, and coping.

This study applies a structured eHealth intervention grounded in Self-Determination Theory to enhance autonomy, competence, and relatedness among cancer patients. The intervention includes synchronous online sessions, digital educational materials, and ongoing communication via mobile platforms over six weeks. Outcomes are measured using validated self-management and coping scales before and after the intervention. The study contributes evidence on the effectiveness of digital health interventions within the Saudi Arabian healthcare context.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

This is an open-label study. Participants and investigators are aware of group assignments.

入排标准

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

入选标准

  • Male and female adult cancer patients
  • Diagnosed with cancer and currently receiving chemotherapy
  • Able to read and understand Arabic
  • Own a mobile phone and able to use online applications (e.g., Zoom or similar platforms)
  • Willing to participate in the eHealth educational program
  • Provided informed consent to participate in the study

排除标准

  • Patients with severe cognitive impairment or psychiatric disorders that interfere with participation
  • Patients with critical health conditions preventing attendance in the intervention sessions
  • Patients who participated in similar structured educational or coping programs during the study period
  • Patients unwilling to complete baseline or follow-up assessments

研究组 & 干预措施

Structured eHealth Intervention Group

Experimental

Participants receive a structured eHealth educational intervention program delivered over six weeks in addition to routine care. The program focuses on enhancing self-management skills and psychological coping strategies among cancer patients.

干预措施: Structured eHealth Educational Intervention (Behavioral)

Routine Care Control Group

No Intervention

Participants receive routine care provided by the healthcare facility without additional eHealth educational intervention.

结局指标

主要结局

Change in Symptom-Management Self-Efficacy Score

时间窗: Baseline and 6 weeks (immediately post-intervention)

Measured using the Symptom-Management Self-Efficacy Scale (SMSE) developed by Liang et al. (2015). The scale consists of 27 items across three subscales: acquiring problem-solving (7 items), managing chemotherapy-related symptoms (15 items), and managing emotional and interpersonal disturbance (5 items). Each item is scored on an 11-point scale ranging from 0 (not at all confident) to 10 (completely confident). The total possible score ranges from 0 to 270. Higher scores indicate greater perceived self-efficacy in symptom management.

次要结局

  • Change in Coping Behavior Score(Baseline and 6 weeks (post-intervention))
  • Correlation Between Self-Efficacy and Coping Scores(6 weeks (post-intervention))

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Manal Saleh Moustafa Saleh

Principal Investigator, Professor, Nursing Administration, Faculty of Nursing, Zagazig University, Zagazig, Egypt.

Zagazig University

研究点 (1)

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