| CTRI Number |
CTRI/2024/07/070768 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of multi-modal interventions on quality of life, symptom burdens and self efficacy among ovarian cancer patients |
|
Scientific Title of Study
|
Effectiveness of multi-modal interventions on Quality of life, symptom burdens and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitali Biswas |
| Designation |
Principal |
| Affiliation |
Tata Medical Center |
| Address |
Department-Nursing.
Division- Academic.
Room No- 105.
Tata Medical Center
14 Major Arterial Road (EW)
Newtown, Rajarhat
Kolkata
Kolkata
WEST BENGAL
700160
India |
| Phone |
918777042912 |
| Fax |
|
| Email |
chaitali.mphil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaydip Bhaumik |
| Designation |
Consultant and Head of the department |
| Affiliation |
Tata Medical Center |
| Address |
Department- Gynaecological oncology.
Room Number-105.
14 Major Arterial Road, (EW)
Newtown, Rajarhat
Kolkata
WEST BENGAL
700160
India |
| Phone |
919748181117 |
| Fax |
|
| Email |
jaydip.bhaumik@tmckolkata.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaydip Bhaumik |
| Designation |
Consultant and Head of the department |
| Affiliation |
Tata Medical Center |
| Address |
Department- Gynaecological oncology.
Room No- 105.
14 Major Arterial Road, (EW)
Newtown, Rajarhat
Kolkata
WEST BENGAL
700160
India |
| Phone |
919748181117 |
| Fax |
|
| Email |
jaydip.bhaumik@tmckolkata.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chaitali Biswas |
| Address |
Tata Medical Center.
14 Major Arterial Road (EW).
Newtown Rajarhat. Kolkata
West Bengal. 700160 |
| 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 Jaydip Bhaumik |
Tata Medical Center |
Department- Gynaecological oncology.
Room No-105
Kolkata
WEST BENGAL |
919748181117
jaydip.bhaumik@tmckolkata.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi-modal interventions |
Multi-modal interventions refer to four multi-component nursing interventions sessions as pre-treatment session, sensitization session, prehabilitation session and symptom management session through various modes of instructions (individual interactions, information booklets, Video guided exercises, diet plan, video guided counseling), each session has planned to conduct on different days within a period of 1 to 21 days after confirm diagnosis of Ovarian cancer. It will be reinforced and monitored through telephonic conversation and in each follow up visit at the out patient department after every three months interval till six month of the treatment.It will be given to the experimental arm |
| Comparator Agent |
Routine care as active control |
Control group will receive the routine verbal advise in each follow up visit at the out patient department after every three months interval till the completion of the treatment. This will be given by the consultant as routine advise. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Newly diagnosed Ovarian cancer patients
1. With any stage from II, III, and IV.
2. Eastern Cooperative Oncology group (ECOG) performance status within 2.
3. Planned for initial treatment either with chemotherapy or Surgery.
4. Able to understand, read, and write Bengali or Hindi or English.
5. Who are willing to be a part of the study |
|
| ExclusionCriteria |
| Details |
Ovarian cancer patients who are
1. Critically ill.
2. ECOG performance status more than 2.
3. Diagnosed as a relapse of ovarian cancer patients.
4. under palliative care |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of multi-modal interventions on Quality of life, Symptom management and self-efficacy among ovarian cancer pateints |
Quality of life, Symptom burdens, and self-efficacy as the outcome of the multi-modal intervention will be assessed at baseline, 3 month, 6 month and 9 month for both experimental arm and control arm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To encourage and motivate the individual Ovarian cancer patients under study to adapt the intervention in their daily life and thus to improve the self-efficacy and self management of symptoms and health related quality of life |
at 9 months after the study as well as continue throughout the survival period |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="9"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [CBISWAS_1960@YAHOO.COM].
- For how long will this data be available start date provided 31-03-2026 and end date provided 31-03-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a single-center, randomized, parallel-group open trial to assess the effectiveness of multi-modal interventions on quality of life, symptom burdens, and self-efficacy among ovarian cancer patients in a selected oncology hospital, Kolkata. The study aims to prepare & implement multi-modal interventions to determine QOL, symptom burdens & self-efficacy among Ovarian cancer patients. The study will follow an RCT design for 9 months of each patient’s coverage. Multi-modal interventions include four multi-component nursing intervention sessions (Pre-treatment session, Sensitization session, Prehabilitation session, and Symptom management session) through various modes of instruction; each session will be on Four different days within the period of 1 to 21 days. It will be given only to the experimental group of ovarian cancer patients
undergoing treatment with surgery or chemotherapy to improve their Quality of
life and self-efficacy and to reduce their symptom burdens. Multi-modal
interventions will be reinforced and monitored through telephonic conversation
and in each follow-up visit at the Outpatient department every three months
till six months of the treatment.
Standardized tools will be used to collect data as a baseline & every 3-month intervals after the implementation of the intervention for both groups of participants. The study’s primary objective is to evaluate the effect of multi-modal interventions on quality of life, symptom burdens, and self-efficacy among ovarian cancer patients. The secondary outcome is encouraging and motivating the individual to adapt the intervention daily to improve self-efficacy, self-management, and health-related quality of life. Based on the findings, this can be implemented as routine care for ovarian cancer patients.
|