NCT Number: NCT06971263
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.
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Request InfoHealthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: From enrollment to the end of interventions at 10 weeks.
The Eastern Cooperative Oncology Group's (ECOG) scale will be used to determine the performance status (PS). The ECOG divides performance scales into five categories: "Zero- fully active"; "One -limited in physically demanding activity but ambulatory and able to perform work of a light or sedentary nature"; "Two- refers to being ambulatory and capable of all self-care but unable to perform any work activities"; "Three- limited capacity for self- care"; "Four- refers to being completely inactive"; and "Five- Dead".
Time frame: From enrollment to the end of interventions at 10 weeks.
The EORTC-QLQ-C30 will be used in all patients to assess Quality of Life. This instrument is a 30-item cancer-specific questionnaire including six function scales (physical, emotional, cognitive, social, role, and global health/QoL), three symptom scales (fatigue, pain, nausea/ vomiting), and six single items assessing symptoms and the financial impact of the disease. Higher scores on the function scales indicate better functioning whilst higher scores on the symptom scales and single items denote increased symptomatology or worse financial impairment. Original scores will be linearly transformed to obtain quantified scores within the range 0 to 100. In addition, for better validation in the clinical context, overall scores derived from function scales, symptom scales and single items, will be calculated on the basis of the very high statistical significance of inter-scale correlations according to to EORTC's guidelines.
Contact information is provided by the study sponsor or research team.
Mahfuza Mubarak, PhD
CONTACT
Syed Billal Hossain, MPH
CONTACT
Jahangirnagar University
Other
Acronym: Consult Cancer
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