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

Обзор

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.

Вмешательства

• Поведенческое Consultation on both nutrition, and palliative care
  The intervention on the nutrition and palliative care components will include open-ended consultations based on ESPEN practical guidelines on nutrition in cancer patients with one cancer center dietitian and one palliative care physician to discuss patient needs and required to improve their health consequences.
• Поведенческое Counselling on nutrition and healthy diet
  The intervention on the nutrition and healthy diet components will include open-ended consultations based on ESPEN practical guidelines on nutrition in cancer patients with one cancer center dietitian to discuss patient dietary needs for improving their health consequences.

Первичные конечные точки

• Patient-Generated Subjective Global Assessment (PG-SGA) Scale [Срок оценки: From enrollment to the end of interventions at 10 weeks.]

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Bangladesh · 3 центра

• Chittagong Medical College Hospital (CMCH) — Chittagong
• Department of Public Health and Informatics, Jahangirnagar University — Savar Upazila
• Mymensingh Medical College Hospital (MMCH) — Mymensingh

Идентификаторы

NCT: NCT06971263 · BBEC-JU-M2025-02-199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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