| CTRI Number |
CTRI/2025/04/085666 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse-led Nutrition and exercise intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
exercise and nutrition program by nurse on gastro-intestinal cancer patients. |
|
Scientific Title of Study
|
A Randomized Controlled Trial (RCT) to assess the effect of nurse-led nutrition and exercise intervention on nutritional status, activities of daily living and quality of life among patients with gastro-intestinal cancer at IRCH, AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Akansha |
| Designation |
M.Sc Nursing Student |
| Affiliation |
College of Nursing AIIMS New Delhi |
| Address |
Porta cabin-2 College of Nursing AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
08700855685 |
| Fax |
|
| Email |
akansha87008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjwal Dahiya |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing AIIMS New Delhi |
| Address |
Room no. 3 College of Nursing AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9899770134 |
| Fax |
|
| Email |
ujjwaldahiya3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Akansha |
| Designation |
M.Sc. Nnursing Student |
| Affiliation |
College of Nursing AIIMS New Delhi |
| Address |
Porta cabin-2 College of Nursing AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
08700855685 |
| Fax |
|
| Email |
akansha87008@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Akansha |
| Address |
Porta cabin 2 College of Nursing, AIIMS New Delhi-110029 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Akansha |
IRCH AIIMS New Delhi |
Surgical Oncology OPD IRCH AIIMS New Delhi
New Delhi
DELHI |
08700855685
akansha87008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led nutrition and exercise intervention. |
Nurse-led nutrition and exercise will be given to intervention group at the time of recruitment and follow up will be done at 1st month, 2nd month and 3rd month by researcher at IRCH AIIMS New Delhi. |
| Comparator Agent |
Standard care |
care will be given as per standard of IRCH protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are 18 years
Able to understand English or Hindi language
Diagnosed with Gastro intestinal cancer
1-2 cycle of Neo Adjuvant therapy
Eastern Cooperative Oncology Group
Performance Status Score from 1 to 4
Having at least one caregiver of age more than 18 years
Patients who are physically and mentally stable. |
|
| ExclusionCriteria |
| Details |
Patients who were unwilling to participate will be excluded from the study
Patients who cannot read and write Hindi & English language
Patients with advanced cancer |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| nutritional status |
at base line at 1 month at 2 month at 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| activities of daily living |
at base line at 1 month at 2 month at 3 month |
| quality of life |
at base line at 1 month at 2 month at 3 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
30/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The thesis research protocol focuses on a randomized controlled trial (RCT) to assess the impact of a nurse-led nutrition and exercise intervention on the nutritional status, activities of daily living, and quality of life among patients with gastrointestinal cancer at IRCH, AIIMS New Delhi. The study aims to evaluate how such an intervention can improve patient outcomes compared to standard care. The primary objectives include assessing changes in nutritional status, activities of daily living, and quality of life, while the secondary objectives explore the relationships between demographic factors and outcomes, along with patient satisfaction. A total of 300 patients will participate, randomized into intervention and control groups, with the intervention group receiving structured dietary advice and supervised exercise plans for 8 weeks. Data collection will include tools like biophysiological assessments and validated questionnaires. The study aims to address gaps in low-resource settings, providing a model for cost-effective, sustainable care to enhance patient recovery and quality of life. |