| CTRI Number |
CTRI/2025/12/098657 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Find Sleep Problems in Advanced Cancer Patients With help of a Sleep Survey and One-on-One Personal Interviews |
|
Scientific Title of Study
|
Prevalence And Experience Of Sleep Disturbances In Patients With Advanced Cancer On Best Supportive Care Referred To Specialist Palliative Medicine Clinic In A Tertiary Cancer Care Centre In India: A Mixed Methods Study Using The Pittsburgh Sleep Quality Study And Semi-Structured Interviews |
| Trial Acronym |
Nidra study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghu Thota |
| Designation |
Professor Palliative Medicine |
| Affiliation |
Tata Memorial Hospital, Mumbai. |
| Address |
Department of Palliative Medicine,
Main Building,
Ground Floor,
Tata Memorial Hospital, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769077764 |
| Fax |
|
| Email |
ragstho24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghu Thota |
| Designation |
Professor Palliative Medicine |
| Affiliation |
Tata Memorial Hospital, Mumbai. |
| Address |
Department of Palliative Medicine,
Main Building,
Ground Floor,
Tata Memorial Hospital, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769077764 |
| Fax |
|
| Email |
ragstho24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghu Thota |
| Designation |
Professor Palliative Medicine |
| Affiliation |
Tata Memorial Hospital, Mumbai. |
| Address |
Department of Palliative Medicine,
Main Building,
Ground Floor,
Tata Memorial Hospital, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769077764 |
| Fax |
|
| Email |
ragstho24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,
Dr. E. Borges Road,
Parel East, Mumbai - 400012,
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E. Borges Road,
Parel East, Mumbai 400012,
Maharashtra, India.
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Raghu Thota |
Tata Memorial Hospital |
Room no 75, Department of Palliative Medicine, Main Building,Ground Floor, Tata Memorial Hospital Mumbai.
Mumbai
MAHARASHTRA |
09769077764
ragstho24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults (less than equal to 18 years) with advanced cancer
Best supportive care,
Referred to palliative care,
Able to provide informed consent.
Able to communicate and understand English/Hindi/Marathi.
|
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment,
Delirium
Inability to communicate.
Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of sleep disturbances in advanced cancer patients using the Pittsburgh Sleep Quality Index (PSQI). |
Single time point at Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the lived experiences, perceived causes, and coping strategies for sleep disturbances in this population through structured interviews. |
Single time point at Baseline |
| To determine the factors associated with sleep disturbances with as graded on ESAS and themes on qualitative interviews. |
Single time point at Baseline |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many people with advanced cancer struggle with poor sleep, which can affect their quality of life and overall well-being. Sleep problems in these patients may include trouble falling asleep, frequent awakenings, or not feeling rested even after sleep. These issues are often overlooked in cancer care, especially in palliative settings, where the focus is usually on managing pain and other physical symptoms. This study aims to find out how common sleep disturbances are among adults with advanced cancer who are no longer receiving active cancer treatment and are instead receiving supportive care. It also seeks to understand their personal experiences of sleep issues what causes them, how they affect their lives, and what coping methods they use. The study is being carried out at Tata Memorial Hospital in Mumbai. It will use two approaches: Quantitative (numerical) data: Around 207 patients will be asked to complete a sleep questionnaire (Pittsburgh Sleep Quality Index or PSQI) to measure how well they sleep. - Qualitative (interview based) data: A smaller group (20 to 25 patients who report sleep issues) will be interviewed in detail to explore their personal experiences, beliefs, and coping strategies related to sleep. The study does not involve any treatment or tests and will be conducted through interviews and questionnaires. Patients can choose not to answer questions or leave the study at any point. If any emotional distress arises during interviews, trained counselors will be available to help. This research is important because it focuses on patients in India a group for whom sleep-related issues in cancer care is not well studied. The findings may help improve the way sleep problems are identified and managed in palliative care settings. |