Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh
Consult Cancer
1 other identifier
interventional
215
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Jun 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
June 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedSeptember 2, 2025
August 1, 2025
10 months
April 17, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient-Generated Subjective Global Assessment (PG-SGA) Scale
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.
From enrollment to the end of interventions at 10 weeks.
Secondary Outcomes (1)
Eastern Cooperative Oncology Group's (ECOG) scale
From enrollment to the end of interventions at 10 weeks.
Other Outcomes (1)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC-QLQ-C30) scale
From enrollment to the end of interventions at 10 weeks.
Study Arms (3)
Cancer patients with both face-to face nutrition and palliative care counselling
ACTIVE COMPARATORRecruited cancer patients will be given both nutrition and palliative care counselling during face-to face surveys.
Cancer patients with face-to face nutrition counselling
ACTIVE COMPARATORRecruited cancer patients will be given nutrition counselling on healthy diet during face-to face surveys.
Cancer patients without any consultation or intervention
NO INTERVENTIONRecruited cancer patients will not be given any nutrition and palliative care counselling or interventions during face-to face surveys.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Cancer Patients under standard treatment, Willing to participate, Who can eat orally, and Health indicators are measurable.
You may not qualify if:
- Cancer Patients under no standard treatment, Not willing to participate, Who cannot eat orally, Health indicators are not measurable, and Death.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chittagong Medical College Hospital (CMCH)
Chittagong, Chattogram, 4203, Bangladesh
Department of Public Health and Informatics, Jahangirnagar University
Savar Upazila, Dhaka Division, 1342, Bangladesh
Mymensingh Medical College Hospital (MMCH)
Mymensingh, Mymensingh, 2200, Bangladesh
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Syed Billal Hossain, MPH
Jahangirnagar University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Data collectors
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
April 17, 2025
First Posted
May 14, 2025
Study Start
June 15, 2025
Primary Completion
April 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- April 2026 to March 2028
- Access Criteria
- Access to IPD will be given on reasonable requests related to research, review and citation.
IPD related to the cancer patients with intervention might be shared on reasonable requests related to research, review and citation.