| CTRI Number |
CTRI/2025/03/083008 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Psycho oncological therapy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of psycho oncological intervention like CALM therapy in cancer patients to improve the quality of life. |
|
Scientific Title of Study
|
Impact of CALM therapy:Advanced Cancer and Living Meaningfully-a psychological intervention in advanced gynecological cancers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepika Rajkumar |
| Designation |
Postgraduate.Mch resident |
| Affiliation |
Amrita Institute of medical science,Amrita Vishwa vidhyapeetham |
| Address |
Gyneconcology department,
Amrita Institute of medical science,Kochi
Ernakulam
KERALA
682024
India |
| Phone |
9962537929 |
| Fax |
|
| Email |
deepika10obgyn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyabhati |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute of medical science,Amrita Vishwa vidhyapeetham |
| Address |
Gyneconcology department,
Amrita Institute of medical science,Kochi
Ernakulam
KERALA
682024
India |
| Phone |
9786630346 |
| Fax |
|
| Email |
priyabhati@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyabhati |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute of medical science,Amrita Vishwa vidhyapeetham |
| Address |
Gyneconcology department,
Amrita Institute of medical science,Kochi
Ernakulam
KERALA
682024
India |
| Phone |
9786630346 |
| Fax |
|
| Email |
priyabhati@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of medical sciences,Ponnekara
Road,P.O,Edapally,Kochi,
Ernakulam ,Kerala,
India-682041 |
|
|
Primary Sponsor
|
| Name |
Dr Deepika Rajkumar |
| Address |
Mch resident,Department of gyneconcology,Amrita Institute of medical sciences,Ponnekara Road,P.O,Edapally,Kochi, Ernakulam ,Kerala, India-682041 |
| Type of Sponsor |
Other [Self] |
|
|
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 Deepika rajkumar |
Amrita Institute of medical sciences |
3-0 OPD,A block,
Department of Gyneconcology,AIMS.
Ernakulam
KERALA |
9962537929
deepika10obgyn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Amrita School of medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, (2) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CALM Therapy |
A psychological therapy used for improving quality of life in advanced cancer patients |
| Comparator Agent |
No CALM therapy |
quality of life in patients given CALM therapy and in patients not given any treatment willl be compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Advanced gynecological cancer patients without any previous history of pshychological disorders and who are influenced in Malayalam and English |
|
| ExclusionCriteria |
| Details |
Early stage gynecological cancer patients and not influent in english and malayalam and not consenting for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of CALM therapy intervention on depression and on anxiety in advanced gynecological cancer patients. |
Baseline assessment of depression and anxiety in advanced gynecological cancer patients at the time of diagnosis before providing any intervention and at the end of 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the incidence of depression and on anxiety in advanced gynecological cancer patients and to assess the impact of CALM therapy intervention on quality of life in cancer patients and to evaluate the effectiveness of CALM therapy and to assess the possibility of executing CALM therapy as a usual routine care in our institute |
Baseline assessment of depression and anxiety in advanced gynecological cancer patients at the time of diagnosis before providing any intervention and at the end of 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="2"
Months="0"
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
|
Depression and anxiety is a very common in advanced gynecological cancer patients.CALM therapy is an acronym for Advanced Cancer and Living meaningfully.CALM therapy is a validated therapy to improve the quality of life in cancer patient.Many trials have been conducted assessing the effectiveness of CALM therapy.Advanced stage gynecological cancer patients will be recruited and randomised into case and control.Baseline assessment of deprerssion and anxiety and their current quality of life will be assessed by validated psychological questionarres like GAD 7,PHQ 9 and QUAL -EC.CALM therapy will be given to patients in case group -minimum 3-6 sessions will be given.Reassessment will be done at the end of 3 months and 6 months for all patients in control and case group and effectiveness of CALM therapy over depression,anxiety and quality of life of cancer patients will be assessed.CALM therapy is already studied by Rickinder sethi et al.,Gary Rodin et al.,Christopher lo et al.,and many others.In all these studies there was no adverse effect documented and found to be beneficial in cancer patients |