| CTRI Number |
CTRI/2017/06/008732 [Registered on: 01/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intervention on anxiety, depression, fatigue, treatment related knowledge and practices in cervical cancer patients |
|
Scientific Title of Study
|
A quasi experimental study to assess the effectiveness of an interventional package on the level of anxiety,depression, fatigue, treatment related knowledge and practices among patients with Cervical cancer under treatment in the department of Radiotherapy, PGIMER, Chandigarh,2015-2017. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mandeep Kaur |
| Designation |
M.Sc(N) student |
| Affiliation |
National Institute of Nursing Education,PGIMER, Chandigarh, Sector 12, pin code 160012 |
| Address |
VPO JANDIALI (NEAR KOHARA) DISTT LUDHIANA. PIN CODE 141112
PUNJAB
National Institute of Nursing Education,PGIMER,Chandigarh, Sector 12, Pin code 160012
Ludhiana
PUNJAB
141112
India |
| Phone |
9501900671 |
| Fax |
|
| Email |
amanpreet00672@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana |
| Designation |
Assistant professor |
| Affiliation |
,Department of Radiotherapy,PGIMER |
| Address |
Department of Radiotherapy,Nehru hospital,PGIMER, Chandigarh, Sector 12
Pin code 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008391 |
| Fax |
|
| Email |
bhavana1035@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Meenakshi Agnihotri |
| Designation |
Clinical instructor |
| Affiliation |
National Institute of Nursing Education,PGIMER,Chandigarh, Sector 12, Pin code 160012 |
| Address |
National Institute of Nursing Education,PGIMER,Chandigarh, Sector 12, Pin code 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872885336 |
| Fax |
|
| Email |
smrishima@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mandeep Kaur |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh Sector 12, Pin Code 160012
|
| Type of Sponsor |
Other [other [Self]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhavana |
Department of Radiotherapy, Nehru Hospital, PGIMER, Chandigarh, Sector 12, Pin code 160012 |
| Dr Karobi Das |
National Institute of Nursing Education, PGIMER, Chandigarh Sector 12, Pin Code 160012
|
| Dr Sandhya Ghai |
National Institute of Nursing Education, PGIMER, Chandigarh Sector 12, Pin Code 160012 |
| Ms Meenkashi Agnihotri |
National Institute of Nursing Education, PGIMER, Chandigarh Sector 12, Pin Code 160012
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mandeep Kaur |
PGIMER, Chandigarh. |
Room no 5, first floor, B Block, Department of Radiotherapy, Nehru Hospital, PGIMER, Chandigarh, Pin Code 160012
Chandigarh
CHANDIGARH |
9501900671
amanpreet00672@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Room No 6006, sixth floor, Research block-B, PGIMER, Chandigarh. Study is Approved under no. NK/2694/M.Sc/265 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical cancer patients undergoing Chemo/ radiotherapy , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jacobson Progressive muscle relaxation, Counselling, Home care techniques |
Seven sessions of Jacobson Progressive muscle relaxation.
two sessions of Counseling at first and third week of therapy.
Home care techniques taught by information booklet given to patient on enrollment |
| Comparator Agent |
routine care |
Routine care includes pre procedure preparation for therapy, during procedure monitoring of patient and post procedure for assesing the side effects and giving health education. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
All patients of cervical cancer undergoing radical/chemo radiotherapy |
|
| ExclusionCriteria |
| Details |
Exclusion : Patients having prior malignancy other than cervical cancer
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence and reduction in the level of anxiety, depression, fatigue and increase in treatment related knowledge and practices |
four and half weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects of chemotherapeutic agents and radiotherapy |
four and half weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a experimental, parallel group, two arm study to assess the effectiveness of interventional package on the level of anxiety, depression, fatigue, treatment related knowledge and practices among patients with cervical cancer. The primary outcome is to evaluate the incidence and reduction in the level of anxiety, depression, fatigue and increase in treatment related knowledge and practices |