| CTRI Number |
CTRI/2019/06/019624 [Registered on: 11/06/2019] Trial Registered Prospectively |
| Last Modified On: |
07/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of cognitive training interventions among Breast cancer patients |
|
Scientific Title of Study
|
A randomized control trial to assess the effectiveness of cognitive training interventions on selected outcome variables among breast cancer patients attending selected OPDs, PGIMER,Chandigarh 2019-20. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deeksha Sharma |
| Designation |
M.sc Student |
| Affiliation |
National Institute of Nursing Education PGIMER Chandigarh. |
| Address |
National Institute of Nursing Education PGIMER Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018702750 |
| Fax |
|
| Email |
deekshagarg4244@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Dutta |
| Designation |
lecturer |
| Affiliation |
National Institute of Nursing Education PGIMER Chandigarh. |
| Address |
National Institute of Nursing Education PGIMER Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deeksha Sharma |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education PGIMER Chandigarh. |
| Address |
National Institute of Nursing Education PGIMER Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018702750 |
| Fax |
|
| Email |
deekshagarg4244@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National institute of nursing education PGIMER Chandigarh |
| Address |
National institute of nursing education PGIMER Chandigarh 16OO12 |
| 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 |
| Deeksha Sharma |
PGIMER Chandigarh |
Post graduate institute of medical and educational research Chandigarh 160012
Chandigarh
CHANDIGARH |
7018702750
deekshagarg4244@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Therapy Interventions |
cognitive training interventions package includes educational information, exercises(mental and physical)verbal session on coping skill enhancement and telephonic reinforcement |
| Comparator Agent |
Routine care |
Routine care including general information about side effects ts of chemotherapy and about physical exercises will be provided to the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Breast cancer patients scheduled for first cycle of chemotherapy and patients receiving doxorubicin and paclitaxel as chemotherapeutic agents, literate patients up to metric standards
|
|
| ExclusionCriteria |
| Details |
having previous cancer diagnosis, patients having neurological and mental health disorders, not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognitive function including memory attention concentration and coping strategies |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect on depression |
5 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/06/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study is not yet published and after the completion of the study it will be published in good authentic journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized control trial to assess the effectiveness of cognitive training interventions that includes educational information, exercises(verbal and mental). verbal session on coping strategies enhancement and telephonic reinforcement on selected variables among breast cancer patients. |