Clinical trial NCT06971263: Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh
Official title: Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Dietary Consultation
Palliative Care
Quality of Life
Performance Status
Nutritional Status
Lead sponsor: Jahangirnagar University
Sponsor class: OTHER
Collaborators: name: Bangladesh University Grants Commission (UGC)
First posted: 2025-05-14
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial (RCT)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Patient-Generated Subjective Global Assessment (PG-SGA) Scale
timeFrame: From enrollment to the end of interventions at 10 weeks.
Secondary outcomes:
measure: Eastern Cooperative Oncology Group's (ECOG) scale
timeFrame: From enrollment to the end of interventions at 10 weeks.
Other outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC-QLQ-C30) scale
timeFrame: From enrollment to the end of interventions at 10 weeks.
Locations:
city: Savar
country: Bangladesh
facility: Department of Public Health and Informatics, Jahangirnagar University
state: Dhaka
Study officials:
affiliation: Jahangirnagar University
name: Syed Billal Hossain, MPH
role: PRINCIPAL_INVESTIGATOR
References: