跳至主要内容
临床试验/NCT06971263
NCT06971263招募中不适用

Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh

Jahangirnagar University5 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2025年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
215
试验地点
5
主要终点
Patient-Generated Subjective Global Assessment (PG-SGA) Scale

研究概览

简要总结

Cancer patients are more likely to have malnutrition, which has been associated with poorer quality of life, higher morbidity, mortality rates, and impaired efficacy and tolerance to therapy. Malnutrition is thought to afflict the cancer patients, with weight loss and varied degrees of asthenia being the main symptoms. In fact, malnutrition can increase the risk of surgical complications such as anastomosis dehiscence, poor wound healing, morbidity, and mortality. Quality of Life is among the most important health issues for cancer patients. Patients view it as a specific and complex type of patient-reported outcomes (PROs) that considers their social, economic, psychological, and physical activities. The quality of life for cancer patients is often lower than for the general population. Despite the fact that several studies in the Western population have suggested a relationship between nutritional status and quality of life (QoL). There aren't many reliable, in-depth studies on the effectiveness of nutritional testing and early malnutrition therapy, as well as to look at the nutritional health and quality of life of cancer patients in Bangladesh. Therefore, the aim of this study is to outline the Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh. To conduct this randomized control trial (RCT), data will be collected through 3 observations: baseline survey with two follow-up surveys on the following months from the selected cohorts of cancer patients who will be receiving cancer treatments. There will be two groups of cohort, one will be given nutrition and palliative care counselling will be given as intervention during each observation and another group will be without consultancy. "The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC-QLQ C30)", "The Patient-Generated Subjective Global Assessment PG-SGA)" to estimate nutritional status, and "The Eastern Cooperative Oncology Group's (ECOG) scale" to determine the performance status (PS) will be used as instruments to collect data.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Data collectors

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Cancer Patients under standard treatment, Willing to participate, Who can eat orally, and Health indicators are measurable.

排除标准

  • •Cancer Patients under no standard treatment, Not willing to participate, Who cannot eat orally, Health indicators are not measurable, and Death.

研究组 & 干预措施

Cancer patients without any consultation or intervention

No Intervention

Recruited cancer patients will not be given any nutrition and palliative care counselling or interventions during face-to face surveys.

Cancer patients with both face-to face nutrition and palliative care counselling

Active Comparator

Recruited cancer patients will be given both nutrition and palliative care counselling during face-to face surveys.

干预措施: Consultation on both nutrition, and palliative care (Behavioral)

Cancer patients with face-to face nutrition counselling

Active Comparator

Recruited cancer patients will be given nutrition counselling on healthy diet during face-to face surveys.

干预措施: Counselling on nutrition and healthy diet (Behavioral)

结局指标

主要结局

Patient-Generated Subjective Global Assessment (PG-SGA) Scale

时间窗: From enrollment to the end of interventions at 10 weeks.

The Patient-Generated Subjective Global Assessment (PG-SGA) instrument will be used to diagnose nutrition. The technique permits categorizing the nutritional evaluation into three groups: A for well-nourished, B for suspected or moderate malnutrition, and C for severe malnutrition. Weight in kilograms divided by height in squared meter is known as the body mass index (BMI). In addition to PG-SGA, BMI will be calculated and categorized according to the age-specific and sex-specific chart created by the US Centers for Disease Control and Prevention.

次要结局

  • Eastern Cooperative Oncology Group's (ECOG) scale(From enrollment to the end of interventions at 10 weeks.)

研究者

发起方
Jahangirnagar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Syed Billal Hossain

PhD Student

Jahangirnagar University

研究点 (5)

Loading locations...

相似试验