| CTRI Number |
CTRI/2018/05/013603 [Registered on: 02/05/2018] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving Quality of Life of cervical cancer patients throug h educational programmes |
|
Scientific Title of Study
|
Comparative impact of two educational intervention strategies for improving Quality of Life of cervical cancer patients reporting at PGIMER, Chandigarh: A two group RCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amudeep Singh |
| Designation |
PhD Scholar |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Community Medicine, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8968947627 |
| Fax |
|
| Email |
amudeep@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarjeet Singh |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Community Medicine, School of Public Health, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814472226 |
| Fax |
|
| Email |
dramarjeet56@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amudeep Singh |
| Designation |
PhD Scholar |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Community Medicine, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8968947627 |
| Fax |
|
| Email |
amudeep@ymail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored (ICMR fellow) |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| 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 |
| Dr Amudeep Singh |
Post Graduate Institute of Medical Education and Research |
Room No. 129, School of Public Health
Chandigarh
CHANDIGARH |
8968947627
amudeep@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
Face to face counseling + Information booklet |
| Comparator Agent |
Group 2 |
Information booklet alone |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
Patients and caregivers willing to participate. |
|
| ExclusionCriteria |
| Details |
Moribund patients |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of life
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in awareness level |
3 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2018 |
| Date of Study Completion (India) |
02/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The
present study was conducted with the following objectives 1- To estimate the
extent and pattern of gynaecological cancer patients reporting at PGIMER,
Chandigarh. 2- To document the existing system of patient handling and
information provision to cervical cancer patients and their family care givers
reporting at PGIMER, Chandigarh. 3- To ascertain the problems faced by cervical
cancer patients and their family care givers regarding illness, diagnosis and
treatment of cervical cancer. 4- To document the information gap amongst cancer
cervix patients and their family care givers regarding various aspects of
cervical cancer. 5- To compare the impact of two educational intervention
strategies (Information booklet with and without face to face counselling) on
Quality of Life of cervical cancer patients reporting at PGIMER, Chandigarh. Retrospective
data from 2012-2016 was collected from hospital records to document the case
load of gynaecological cancer admissions. Further, a Randomized Control Trial
was conducted
at the Department of Gynaecology and Department of Radiotherapy of PGIMER,
Chandigarh from July 2018 to August 2019. A total of 180 cervical cancer
patients were randomized into two groups viz. Intervention group (Information
booklet and two face to face counselling sessions) and Control group
(information booklet alone). The
patients recruited for the RCT were also interviewed for problems faced and
Information gap. All patients were followed up twice during a six-month
interval. Minimum interval between any two visits was one month. EORTC QLQ-C30
and EORTC QLQ-CX 24 tools were used to assess the Quality of Life at Baseline
and subsequent Follow ups.
An average annual case load
for gynaecological cancer admissions of 795 was noted for PGIMER, Chandigarh
during the period from 2012 to 2016. Results show that Loss
of appetite, fatigue, anxiety and compromised role functioning were most common
adverse effects reported by >80% women undergoing therapy. Regarding direct care giving, around 80%
family caregivers faced problems in scheduling appointments and coordinating
care. New patients had less information on cancer and its related aspects
compared to Old patients. Patients wished to receive more information diet,
self-care and pain management. A significant improvement in
Quality of Life of post therapy Intervention group (Group A) patients was seen
at second follow up visit on Emotional functioning, Social functioning,
Fatigue, Nausea and vomiting, Insomnia, Constipation, Global Health status, Symptom
experience, Body Image, Lymphedema, Peripheral neuropathy, and Menstrual
symptoms compared to Control Group (Group B) patients. Overall, the intervention group patients who received face to face
counselling and booklet reported better Quality of Life on second follow up
visit as compared to Control group patients who received booklet alone.
|