| CTRI Number |
CTRI/2023/12/060863 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Intimacy, Sexual Communication, and Coping [between couples] among Breast Cancer Survivors and their partners |
|
Scientific Title of Study
|
Intimacy, Sexual Communication, and Dyadic Coping among Breast Cancer Survivors and their partners: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirti Singhal |
| Designation |
M.Phil Trainee |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7840050890 |
| Fax |
|
| Email |
kirtisinghal7991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kirti Singhal |
| Designation |
M.Phil Trainee |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7840050890 |
| Fax |
|
| Email |
kirtisinghal7991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shwetha TS |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Clinical Psychology, Manipal college of Health Professions, Manipal Academy of Higher Education, Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9880993080 |
| Fax |
|
| Email |
shwetha.ts@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Kirti Singhal |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka 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 Shwetha TS |
Kasturba Hospital |
OPD, 1st floor, Medical Oncology Department, Shirdi Sai Cancer Hospital, Manipal, Karnataka
Udupi
KARNATAKA |
9880993080
shwetha.ts@manipal.edu |
|
|
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 |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Heterosexual married female and staying with the male partner for more than 6 months
Dyads who understand English or Kannada
The patient is a female who is a breast cancer survivor (treated 6 months ago)
|
|
| ExclusionCriteria |
| Details |
Couples diagnosed or on treatment for any psychiatric illness (psychosis, mood disorders, substance use disorders, intellectual disability) or any cognitive dysfunction
Dyads with a comorbid cancer of another organ
Couples undergoing any psychological intervention in the past 6 months,
Couples who prefer homosexuality or pansexuality
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The level of intimacy, sexual communication, and dyadic adjustment among the breast cancer survivors and their partners using need for sexual intimacy scale, dyadic sexual communication scale, and abbreviated dyadic adjustment scale |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship between the variables and predict the actor and partner effects of intimacy and sexual communication on dyadic coping among the breast cancer survivors and their partners |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
01/01/2024 |
| 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="6"
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
|
The approval from the institute research committee and the
institute ethics committees has been obtained and currently registering the research with Clinical Trial Registry
of India (CTRI). The identification of the participants and data collection
process will begin from the Shirdi Sai cancer hospital, Manipal. The women and
their partners will be contacted on the outpatient basis, through consecutive
sampling, at the study setting. The informed consent will be given along with
the participant information sheet for their perusal and after explaining about
the research and its objectives, the three scales will be given to them. If the
partners are not present at the hospital, the scales will be sent to them
online to collect the data from them. Immediate telephonic feedback will be
taken from the participants, after completing the scales. |