| CTRI Number |
CTRI/2025/11/096862 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life among women with cancer cervix receiving brachytherapy as a part of treatment in a selected cancer care centre in North east India. |
|
Scientific Title of Study
|
A study to assess the quality of life (QOL) among women with cervical cancer receiving brachytherapy as a part of definitive radiation treatment in a selected cancer care centre, North east India. |
| 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 Yanpothung Yanthan |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Bhubaneswar Borooah cancer Institute |
| Address |
AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
9612551001 |
| Fax |
|
| Email |
yanyanthan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yanpothung Yanthan |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Bhubaneswar Borooah cancer Institute |
| Address |
AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
9612551001 |
| Fax |
|
| Email |
yanyanthan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yanpothung Yanthan |
| Designation |
Assistant Professor |
| Affiliation |
Dr. Bhubaneswar Borooah cancer Institute |
| Address |
AK Azad Road, Gopinath Nagar Rd, Bishnu Rabha Nagar, Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
9612551001 |
| Fax |
|
| Email |
yanyanthan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B. Borooah cancer Institute, Gopinath Nagar, A. K. Azad Road, Guwahati, Kamrup, Assam, 781016 |
|
|
Primary Sponsor
|
| Name |
Dr. B Borooah Cancer Institute |
| Address |
A. K. Azad Road,
Gopinath Nagar, Guwahati
781016 |
| 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 |
| Yorum yama |
Dr. B Borooah Cancer Institute |
A. K. Azad Road, Gopinath Nagar
Guwahati, 781016
Kamrup
ASSAM |
9362730314
yorumyama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical ethics committee, BBCI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patient diagnosed with cervical cancer and undergoing brachytherapy as a part definitive radiation therapy
Patients on follow-up who had completed brachytherapy within the last 3 months.
Adults aged 18 years and above, regardless of menopausal status.
Patients who are willing to participate in the study.
Patients who can understand English, Hindi or Assamese.
|
|
| ExclusionCriteria |
| Details |
Patients with severe co-morbidities such as advanced cardiovascular disease, uncontrolled diabetes, or chronic kidney/liver failure that could independently affect quality of life (QoL) and functionality. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the quality of life among women with cervical cancer receiving brachytherapy as a part of definitive radiation treatment. |
At 4 weeks of conclusion of brachytherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the correlation between the quality of life & the selected demographic variables |
At 8 weeks of conclusion of the sample collections |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2025 |
| 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="14" |
|
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
|
This is prospective observational cross-sectional trial to assess the quality of life in patients of carcinoma cervix receiving brachytherapy as part of their curative treatment. The findings of this research will provide valuable insights for healthcare providers to improve patient centered care, optimize treatment outcomes, and enhance supportive care strategies for cervical cancer patients undergoing brachytherapy. |