| CTRI Number |
CTRI/2025/12/098264 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the impact of stress and coping on quality of life among patients receiving
chemotherapy in a selected hospital Ernakulam. |
|
Scientific Title of Study
|
Impact of stress and coping on quality of life among patients receiving chemotherapy. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anju mariya saju |
| Designation |
Msc Nursing |
| Affiliation |
Lourdes College Of Nursing |
| Address |
Lourdes College Of Nursing
Sidhi Sadan
Chembumukku
Thrikkakara p.o
Kochi
Inpatient and outpatient department of oncology
Lourdes College Of Nursing
Sidhi Sadan
Chembumukku
Thrikkakara p.o
Kochi
Inpatient and outpatient department
Inpatient and outpatient department of oncology
Ernakulam
KERALA
682021
India |
| Phone |
9446083939 |
| Fax |
|
| Email |
anjumariya08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saniya Jose |
| Designation |
Professor |
| Affiliation |
LOURDES COLLEGE OF NURSING |
| Address |
Lourdes College Of Nursing
Sidhi Sadan
Chembumukku
Thrikkakara p.o
Kochi
Lourdes College Of Nursing
Sidhi Sadan
Chembumukku
Thrikkakara p.o
Kochi
Ernakulam
KERALA
682021
India |
| Phone |
8592952722 |
| Fax |
|
| Email |
saniyaseenu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anju mariya saju |
| Designation |
MSc Nursing |
| Affiliation |
Kerala university of health sciences |
| Address |
Lourdes college of nursing
Sidhi sadan
Chembumukku
Thrikkakara p.o
Kochi
Lourdes college of nursing
Sidhi sadan
Chembumukku
Thrikkakara p.o
Kochi
Ernakulam
KERALA
682021
India |
| Phone |
9446083939 |
| Fax |
|
| Email |
anjumariya08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lourdes hospital
Pachalam
Ernakulam
kochi
kerala 682012 |
|
|
Primary Sponsor
|
| Name |
ANJU MARIYA SAJU |
| Address |
LOURDES COLLEGE OF NURSING
SIDHI SADAN
CHEMBUMUKKU
THRIKKAKARA P.O
KOCHI |
| Type of Sponsor |
Other [PRIVATE COLLEGE OF NURSING ] |
|
|
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 |
| Anju mariya saju |
Lourdes Hospital |
Inpatient and out patient department
Ernakulam
KERALA |
09656283939
anjumariya08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lourdes ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D498||Neoplasm of unspecified behavior of other specified sites, (2) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (3) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Sample includes patients who are
18 years and above
Able to read and write
Receiving chemotherapy in outpatient or inpatient departments
Completed at least three chemotherapies
at least one cycle of chemotherapy. |
|
| ExclusionCriteria |
| Details |
Sample Excludes patient who are
Terminally ill
Cognitively impaired
Physically unfit
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceived stress
Coping
Quality of life |
4weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/12/2025 |
| 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="1"
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
|
The purpose of the study is to assess the impact of stress and coping on quality of life among cancer patients receiving chemotherapy. Hypothesis H1 There is significant impact of stress on quality of life among patients receiving chemotherapy H2 There is significant impact of coping on quality of life among patients receiving chemotherapy H3 There is significant association between the stress coping and quality of life among patients receiving chemotherapy with selected sample variables |