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

NCT ID: NCT06971263

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-15

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Control Trial (RCT)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Data collectors

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Consultation on both nutrition, and palliative care

Intervention Type BEHAVIORAL

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.

Cancer patients with face-to face nutrition counselling

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

Group Type ACTIVE_COMPARATOR

Counselling on nutrition and healthy diet

Intervention Type BEHAVIORAL

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.

Cancer patients without any consultation or intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangladesh University Grants Commission (UGC)

UNKNOWN

Sponsor Role collaborator

Jahangirnagar University

OTHER

Sponsor Role lead

Responsible Party

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Syed Billal Hossain

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Syed Billal Hossain, MPH

Role: PRINCIPAL_INVESTIGATOR

Jahangirnagar University

Locations

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Chittagong Medical College Hospital (CMCH)

Chittagong, Chattogram, Bangladesh

Site Status RECRUITING

Department of Public Health and Informatics, Jahangirnagar University

Savar Upazila, Dhaka Division, Bangladesh

Site Status ACTIVE_NOT_RECRUITING

Mymensingh Medical College Hospital (MMCH)

Mymensingh, Mymensingh, Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Syed Billal Hossain, MPH

Role: CONTACT

+8801792564446

Mahfuza Mubarak, PhD

Role: CONTACT

+8801311334033

Facility Contacts

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Dr. Banani Barua, MBBS, M.Phil.

Role: primary

+8801712129595

Dr. Md. Ashraful Islam, MBBS

Role: primary

+8801684155883

Related Links

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https://qol.eortc.org/questionnaire/eortc-qlq-c30/

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

https://pt-global.org/pt-global/

Patient-Generated Subjective Global Assessment (PG-SGA) Nutrition scale

https://ecog-acrin.org/resources/ecog-performance-status/

Eastern Cooperative Oncology Group's (ECOG) Performance Status scale

Other Identifiers

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BBEC-JU-M2025-02-199

Identifier Type: -

Identifier Source: org_study_id

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