| CTRI Number |
CTRI/2025/11/097129 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact Of Stress On Sleep Quality And Quality Of Life In Cancer Patients |
|
Scientific Title of Study
|
A Prospective Study To Assess The Impact Of Perceived Stress On Sleep Quality And Quality Of Life Among Cancer Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA KIRAN KANIYALA HOSAMANE |
| Designation |
student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences,NITTE(Deemed to be University) |
| Address |
Department of Pharmacy Practice, NGSMIPS,Paneer,Derlakatte,
Mangaluru, Dakshina Kannada, Kartanata
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7349712056 |
| Fax |
|
| Email |
nehakaniyala20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Juno J Joel |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences,NITTE(Deemed to be University) |
| Address |
Department of Pharmacy Practice, NGSMIPS,Paneer,Derlakatte,
Mangaluru, Dakshina Kannada, Kartanata
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Juno J Joel |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences,NITTE(Deemed to be University) |
| Address |
Department of Pharmacy Practice, NGSMIPS,Paneer,Derlakatte,
Mangaluru, Dakshina Kannada, Kartanata
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences,NITTE(Deemed to be University),Paneer,Derlakatte, Dakshina Kannada,KARNATAKA 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Neha Kiran Kaniyala Hosamane |
Justice K S Hegde Charitable Hospital |
Department of Oncology,Justice K S Hegde Charitable Hospital,Derlakatte
Mangaluru-575018
Kartanaka, India
Dakshina Kannada
KARNATAKA |
07349712056
nehakaniyala20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient who are 18 years and above with no comorbidities |
|
| ExclusionCriteria |
| Details |
critically ill patients and patients who refuse to give informed consent who have psychological illnes or patients taking medications for sleep disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will provide an overview of stress affecting sleep quality and quality of life in cancer patients. |
The data needed for the study will be collected at the baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the study enables us to correlate the perceived stress, sleep quality and quality of life among the cancer patient |
6 months |
|
|
Target Sample Size
|
Total Sample Size="218"
Sample Size from India="218"
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)
|
24/11/2025 |
| 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
|
Introduction:Cancer is defined as a large group of diseases that initiate from any organ or a tissue of the body, when cells grow abnormally it leads to an invasion of the other parts of the body. This can result in the spread of the disease and if not controlled, it could lead to death. Stress is a natural reaction to any kind of pressure that causes mental tension.Sleep disturbances are often noticed in patients who are undergoing chemotherapy due to psychological stress
Objectives of the study: i. To assess the Perceived stress and sleep quality among cancer patients. ii. To analyse the quality of life and its determinants among the study population. to evaluate the impact of perceived stress on sleep quality and quality of life among the cancer patients
Methodology The Prospective cross-sectional will be conducted in the Department of Oncology, Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru.The sample size to be calculated is approximately 218 patients.Ethical approval will be obtained by the Institutions ethics committee before the commencement of the study. The duration of the study is six months and the patients will be selected based on the inclusion and exclusion criteria. Statistical Analysis Qualitative data will be expressed as frequency and percentage, ie mean ± SD or median (IQR). Chi square/fisher exact test will be used to find association between categorical variables. Independent t-test/ Mann Whitney U- test or one way ANOVA/Kruskal Walli’s test will be used to compare stress, sleep quality and quality of life score between the demographical and clinical characteristics of the participants. Pearson correlation/spearman rank correlation will be used to find the relationship between the quantitative variables (scores).A p value <0.05 will be considered as statistically significant.SPSS software version 29 will be used for data analysis. Anticipated Outcome Through this study we will be able to understand the perceived stress among cancer patients and its impact on sleep quality and quality of life. |