| CTRI Number |
CTRI/2024/10/075295 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Intimacy and Communication in Prostate Cancer Survivors: A Multi-Center Survey |
|
Scientific Title of Study
|
A multi center study survey to explore the relationship between intimacy, dyadic communication, and relationship satisfaction among Prostate Cancer survivors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Advika Goenka |
| Designation |
MPhil Trainee |
| Affiliation |
Manipal College of Health Professions |
| Address |
505, 5th floor common faculty room
Department of Clinical Psychology
Manipal College of Health Professions
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
07022968936 |
| Fax |
|
| Email |
advika.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha TS |
| Designation |
Associate Professor and Head of the Department of Clinical Psychology |
| Affiliation |
Manipal College of Health Professions |
| Address |
505, 5th floor common faculty room
Department of Clinical Psychology
Manipal College of Health Professions
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9880993080 |
| Fax |
|
| Email |
shwetha.ts@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Priyanka Krishnan |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
505, 5th floor common faculty room
Department of Clinical Psychology
Manipal College of Health Professions
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9895316496 |
| Fax |
|
| Email |
priyanka.krishnan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Clinical Psychology
Manipal College of Health Professions
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
576106 |
|
|
Primary Sponsor
|
| Name |
Ms. Advika Goenka |
| Address |
Department Of Clinical Psychology, Manipal College of Health Professions, Manipal- 576104 |
| 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 Karthik S Udupa |
Kasturba Hospital |
2nd Floor, Room 2
Department of Medical Oncology
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA |
9845317153
udupa.karthik@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-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. heterosexual, married, and staying with partner for more than 12 months.
2. Dyads who understand English, Hindi and Kannada
3. An individual who is a prostate cancer survivor; currently cancer-free
|
|
| ExclusionCriteria |
| Details |
1. Dyads diagnosed or on treatment for any psychiatric illness (psychosis, mood disorders, substance use disorders, intellectual disability) or any cognitive dysfunction
2. Dyads with a co-morbid cancer of another organ or any other serious medical conditions
3. Couples undergoing any psychological intervention in the past 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relationships between various moderating variables and their impact on the dynamics between partners dealing with terminal illness.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship between different dyadic Communication patterns and Relationship Satisfaction |
Baseline |
| Relationship between levels of intimacy and overall relationship satisfaction |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="202"
Sample Size from India="202"
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)
|
25/10/2024 |
| 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="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 understand the relationship between intimacy, dyadic communication, and satisfaction in relationships among prostate cancer survivors and their spouses, in a tertiary care center.
Objective(s)- 1. To explore the level of relationship intimacy, dyadic communication, and marital satisfaction among prostate cancer survivors and their partners. 2. To understand the effect of different sub-forms of dyadic communication and intimacy on relationship satisfaction.
Procedure-
Once approvals are obtained, data collection will begin by identifying participants from the Department of Medical Oncology at Kasturba Hospital and private practitioners nationwide. Oncologists will be contacted for permission, and upon approval, a QR code linked to a Google Form with the screening and assessment tools will be provided to the practitioners for data collection. The patients would be identified through the oncologists (both private practitioners and doctors working at hospitals like Kasturba Hospital, Manipal) and subsequently would be asked to fill out the form after their consent. Couples meeting the inclusion criteria will individually complete three scales (Dyadic Communication Pattern Questionnaire, Personal Assessment of Intimacy in Relationships scale, and Relationship Satisfaction scale). Therefore, each partner would fill out all three above-mentioned scales and the scores would be analyzed separately. After filling out the online form, participants will be screened using the General Health Questionnaire (GHQ). Those scoring 2 or less on GHQ-5 will be recruited for data analysis.
Tools- 1. General Health Questionnaire-12 The GHQ-12, widely used for assessing psychological well-being and screening for major mental illnesses, has demonstrated good criterion validity 2. Communication Patterns Questionnaire 35-item to study dyadic communication styles, including constructive communication, self-demand/partner-withdraw, mutual avoidance, and partner-demand/self-withdraw. Responses are rated on a 9-point Likert scale from 1 (extremely improbable) to 9 (very likely). 3. Personal Assessment of Intimacy in Relationships (PAIR) 36-item to assess five types of intimacy: emotional, social, sexual, intellectual, and recreational. It uses a 5-point Likert scale, with scores ranging from 5 to 30. Higher scores indicate greater intimacy, while lower scores indicate less. 4. Relationship Assessment Scale (RAS) Measures a person’s subjective assessment of a close relationship. The scale consists of seven items, each rated from 1 (poor satisfaction) to 5 (great satisfaction).
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