| CTRI Number |
CTRI/2025/12/098414 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Talking With Doctors and Coping With Unpredictable Situations Influence Psychological Growth in Women With Ovarian Cancer
|
|
Scientific Title of Study
|
Impact of Doctor-Patient Communication on Post Traumatic Growth: Mediating Role of Intolerance of Uncertainty in Ovarian Cancer Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ananya Agrawal |
| Designation |
MPhil Clinical Psychology Trainee |
| Affiliation |
Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9910194517 |
| Fax |
|
| Email |
ananya7.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha TS |
| Designation |
Associate Professor and Head |
| Affiliation |
Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9880993080 |
| Fax |
|
| Email |
shwetha.ts@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sebastian Padickaparambil |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India.
Udupi
KARNATAKA
576104
India |
| Phone |
9482916960 |
| Fax |
|
| Email |
sebastian.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self for the monetary support and the Kasturba Medical College and Hospital, Madhav Nagar, Eshwar Nagar Manipal, Karnataka 576104 India for the infrastructure support |
|
|
Primary Sponsor
|
| Name |
Ananya Agrawal |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, 576104, India |
| Type of Sponsor |
Other [Allied Health Sciences College ] |
|
|
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 Shwetha TS |
Kasturba Medical College and Hospital, Manipal |
Department of Medical Oncology and Department of Obstetrics and Gynaecology, Kasturba Medical College and Hospital, Udupi Hebri Rd, Madhav Nagar, Manipal, Karnataka, 576104
Udupi
KARNATAKA |
9880993080
shwetha.ts@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C56||Malignant neoplasm of ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed with Ovarian Cancer, Minimum 1 year post diagnosis during treatment, Currently recieving treatment at Manipal and can understand the questions, women above 18 years |
|
| ExclusionCriteria |
| Details |
Presence of severe psychiatric conditions, Recurrent or terminal cancer diagnosis, Prior diagnosis of another major chronic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out how communication between doctors and patients affects post traumatic growth in women with ovarian cancer, and how their ability to handle uncertainty influences this link. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
14/12/2025 |
| 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="10"
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
|
Aim:
To examine how doctor patient communication and intolerance of uncertainty influence post traumatic growth in individuals with ovarian cancer. Objectives: To assess the impact of patients perception of doctor patient communication on post traumatic growth. To examine whether intolerance of uncertainty mediates the relationship between communication perceptions and post traumatic growth.
Instruments: Sociodemographic Details Sheet: Includes age, gender, education, occupation, years of treatment, cancer stage and type, chronic medical and psychiatric conditions. Patient Centred Communication Cancer 36 PCC Ca 36: Assesses patients perceptions of communication in cancer care across six domains using 36 items rated on a 5 point Likert scale. Higher scores indicate better perceived communication. Intolerance of Uncertainty Scale IUS: A 27 item scale measuring prospective and inhibitory anxiety related to uncertainty. Rated on a 5 point Likert scale, with higher scores indicating greater intolerance of uncertainty. Post Traumatic Growth Inventory PTGI: A 21 item scale assessing positive psychological changes across five domains. Rated on a 6 point scale. Higher scores indicate greater post traumatic growth.
Procedure:
Institutional and ethics approvals will be obtained followed by Clinical Trial Registry of India registration. Recruitment will occur in oncology and gynaecology OPDs through flyers and in person contact. Tools will be translated by certified professionals. Eligible participants will provide informed consent and complete sociodemographic details and standardised scales. Data will be entered into SPSS for descriptive and inferential analysis, and AMOS will be used for mediation analysis through structural equation modelling. Data interpretation will be done by the research team. Data Analysis:
SPSS and AMOS will be used. Statistical Tests: |