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临床试验/NCT07066592
NCT07066592进行中(未招募)不适用

Investigation of the Effects of Prehabilitation Education Delivered Through a Mobile Compatible Website on Quality of Life and Symptoms in Patients Undergoing Hematopoietic Stem Cell Transplantation

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
36
试验地点
1
主要终点
symptom management

研究概览

简要总结

Aim of the Study:

The aim of this study is to examine the effect of prehabilitation education delivered via a mobile-compatible website on the quality of life and symptom evaluation of patients undergoing hematopoietic stem cell transplantation (HSCT).

Research Questions:

What is the effect of prehabilitation education delivered via a mobile-compatible website on the quality of life of stem cell transplant patients? What is the effect of prehabilitation education delivered via a mobile-compatible website on the symptom management of stem cell transplant patients?

Method:

In this study, patients will be randomly assigned to one of two groups:

One group will receive prehabilitation education through a mobile-compatible website.

The other group will receive standard educational procedures.

详细描述

Hematopoietic Stem Cell Transplantation (HSCT) is an intensive treatment with the potential to cure hematologic malignancies and other highly morbid diseases. However, it is also associated with significant risks of morbidity and mortality. Many HSCT patients experience a variety of physical, emotional, and cognitive symptoms, particularly during the acute recovery phase following transplantation. Gastrointestinal symptoms such as nausea, vomiting, loss of appetite, mucositis, and changes in taste often emerge during the pre-transplant conditioning period and may persist for an extended period after the transplant.

Loss of strength and pain are among the most common and severe symptoms during the acute recovery phase. Other frequently encountered symptoms include anorexia, loss of muscle mass, and fatigue. During hospitalization, HSCT patients may also experience clinically significant emotional symptoms such as anxiety, depression, or adjustment disorders. These symptoms can negatively impact patients' subjective symptom burden, treatment adherence, and length of hospital stay.

Therefore, accurate assessment and management of symptoms and risks during hospitalization are essential to minimize the symptom burden in HSCT patients. Since HSCT involves high-dose chemotherapy, prolonged hospital stays, and strict isolation protocols, transplant-specific quality of life (QoL) assessment is crucial. Evaluating QoL in transplant patients can help healthcare professionals understand patients' physical, psychological, and social well-being and identify their rehabilitation needs.

Numerous symptoms caused by the disease and HSCT, as well as transplant-specific complications, significantly reduce patients' quality of life and adversely affect long-term transplant outcomes. For this reason, it is important to prepare patients adequately before undergoing HSCT. In such cases, the concept of prehabilitation is considered essential. Prehabilitation is a clinical model that introduces rehabilitation components to patients before intensive medical interventions, aiming to optimize functionality and improve tolerance to treatment.

Cancer prehabilitation is a part of the cancer rehabilitation care process. It occurs between the time of cancer diagnosis and the start of acute treatment. It includes physical and psychological assessments to establish a baseline functional level, identify impairments, and provide interventions that promote psychological health and physical improvement to reduce the incidence and/or severity of future impairments.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Undergoing Hematopoietic Stem Cell Transplantation (HSCT) for the first time
  • •Having no musculoskeletal problems that would prevent physical activity
  • •Volunteering to participate in the study
  • •Between 18 and 70 years of age
  • •Having access to and the ability to use a mobile phone and the internet
  • •Literate in Turkish (able to read and write in Turkish)

排除标准

  • •Having a condition that prevents effective communication
  • •Being illiterate (unable to read and write)
  • •Inability to use technology

研究组 & 干预措施

Prehabilitation education provided via mobile compatible website

Experimental

Participants will receive access to the educational website containing information on the stem cell transplantation process, consisting of 9 sections, one week prior to hospital admission.

干预措施: Prehabilitation education provided via mobile compatible website (Behavioral)

Control

No Intervention

Participants will receive routine care.

结局指标

主要结局

symptom management

时间窗: The baseline and average 3-4 weeks

Edmonton Symptom Assessment Scale. Each symptom is evaluated using numerical ratings ranging from 0 to 10. A score of 0 indicates that the symptom is absent, while a score of 10 indicates that the symptom is felt very severely. The severity of the symptom increases progressively from 0 to 10. (The changes will be evaluated from the baseline level to the day of transplantation and up to the day of discharge. This period takes approximately 3-4 weeks on average)

quality of functionality

时间窗: The baseline and average 3-4 weeks

Functional Assessment of Cancer Therapy-Bone Marrow Transplant (4th version) The minimum score obtainable from the FACT-BMT scale is 0, and the maximum score is 148. Higher scores indicate a better quality of life. (The changes will be evaluated from the baseline level to the day of transplantation and up to the day of discharge. This period takes approximately 3-4 weeks on average)

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 (1)

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