| CTRI Number |
CTRI/2025/07/091037 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A short psychological program to help women diagnosed with gynaecological cancer manage stress, unhelpful thinking patterns and self-regulation. |
|
Scientific Title of Study
|
Brief Psychological Intervention for Distress, Metacognitive Beliefs and Self-Management in women with gynaecological cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Rekha Samal |
| Designation |
Research Scholar |
| Affiliation |
University of Hyderabad |
| Address |
Centre for Psychology, School of Medical Sciences, University of Hyderabad, Gachbowli, Hyderabad, Telangana
Hyderabad
TELANGANA
500046
India |
| Phone |
07008171139 |
| Fax |
|
| Email |
samal_rashmi@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Rekha Samal |
| Designation |
Research Scholar |
| Affiliation |
University of Hyderabad |
| Address |
Centre for Psychology, School of Medical Sciences, University of Hyderabad, Gachbowli, Hyderabad, Telangana
Hyderabad
TELANGANA
500046
India |
| Phone |
07008171139 |
| Fax |
|
| Email |
samal_rashmi@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Rekha Samal |
| Designation |
Research Scholar |
| Affiliation |
University of Hyderabad |
| Address |
Centre for Psychology, School of Medical Sciences, University of Hyderabad, Gachbowli, Hyderabad, Telangana
Hyderabad
TELANGANA
500046
India |
| Phone |
07008171139 |
| Fax |
|
| Email |
samal_rashmi@ymail.com |
|
|
Source of Monetary or Material Support
|
| University of Hyderabad, Post Lingampally CR Rao Road, Hyderabad Central University Rd, Gachibowli, Hyderabad, Telangana 500046, India |
|
|
Primary Sponsor
|
| Name |
Rashmi Rekha Samal |
| Address |
Centre for Health Psychology, University of Hyderabad, Post Lingampally CR Rao Road, Hyderabad Central University Rd, Gachibowli, Hyderabad, Telangana 500046, India |
| 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 M Ramesh |
MNJ Cancer Hospital |
11-5, 399red hills, Red Hills, Lakdikapul, Hyderabad, Telangana 500004, India
Hyderabad
TELANGANA |
08093995097
samal_rashmi@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC MNJ Institute of Oncology and Regional Cancer Centre |
Approved |
| University of Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Psychological Intervention |
Participants in the intervention group will receive standard medical care provided by the oncology centre, along with a brief psychological intervention. This intervention consists of six individual sessions, delivered once a week over a period of six weeks, each lasting approximately 30 to 45 minutes. The sessions will be conducted in person by a trained psychologist. The content of the sessions is based on cognitive behavioural therapy and mindfulness cognitive behaviour therapy and compassion therapy. It includes psychoeducation, mindful breathing, worry postponement and compassionate letter writing. Participants will be assessed at baseline and again after six weeks, in line with the assessment schedule for the control group. |
| Comparator Agent |
Treatment-as-usual (TAU) |
The standard medical care provided by the oncology centre to the women with gynaecological cancer patients. The group will not receive any additional psychological intervention during the study period. They will not participate in any psychological sessions and will be assessed at the same time points i.e. after six weeks as the intervention group for comparison purposes. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
The study will include women diagnosed with gynaecological cancer, including cervical, ovarian, uterine, fallopian tube, or vaginal cancer, who are married and can read and write in at least one of the following languages: Odia, Hindi, Telugu, or English.
|
|
| ExclusionCriteria |
| Details |
The study will exclude women with gynaecological cancer who do not provide consent, are diagnosed with stage IV cancer, score above 3 on the ECOG Performance Status scale, are unable to attend sessions as advised by their oncologist, have a history of mental health conditions, or have undergone surgery within the past month.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Brief psychological intervention has an impact on distress, metacognitive beliefs and self-management in women with gynaecological cancer. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Brief psychological intervention increases knowledge levels, mindfulness and self-compassion in women with gynaecological cancer. |
6 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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
|
The findings from this study will provide valuable insight into the relationship between these variables to improve and provide quality care to the patients with gynaecological cancer. The purpose here is to modify metacognitive beliefs, and improve emotional distress and self-management in patients with gynaecological cancer. The therapeutic approach adapted in this study is a comprehensive intervention which may create a more sustainable and lasting positive outcomes and be a more helpful intervention for patients with cancer. |