| CTRI Number |
CTRI/2018/02/012123 [Registered on: 23/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding spiritual and religious beliefs of cancer patients and their impact on coping |
|
Scientific Title of Study
|
Spiritual/religious beliefs and their impact on coping in cancer patients: an exploratory study in an Indian setting |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savita Goswami |
| Designation |
Clinical Psychologist |
| Affiliation |
Tata Memoral Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820050072 |
| Fax |
022-24146937 |
| Email |
savitata@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Savita Goswami |
| Designation |
Clinical Psychologist |
| Affiliation |
Tata Memoral Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820050072 |
| Fax |
022-24146937 |
| Email |
savitata@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Savita Goswami |
| Designation |
Clinical Psychologist |
| Affiliation |
Tata Memoral Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820050072 |
| Fax |
022-24146937 |
| Email |
savitata@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Ernest Borges Marg,
Parel, Mumbai - 400012 |
|
|
Primary Sponsor
|
| Name |
Savita Goswami |
| Address |
Psychiatric Unit, Golden Jubilee Block, Basement, Room no-20,Tata Memorial Hospital, Parel, Mumbai |
| 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 |
| Savita Goswami |
Tata Memorial Hospital |
Tata Memorial Hospital, Golden Jubilee Block, Psychiatric Unit,Room No- 20, Dr. Ernest Borges Marg
Parel, Mumbai - 400012
Mumbai
MAHARASHTRA |
9820050072
022-24146937
savitata@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult cancer patients referred to Psycho-oncology service , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult cancer patients above 18 years of age
2. Any cancer site
3. Outpatients
4. On active cancer directed treatment (curative intent) or on follow up after completion of treatment
• Able to participate in 30-45 minutes of in depth interview
• Able to give informed consent
• Marathi, Hindi or English speaking
|
|
| ExclusionCriteria |
| Details |
1. Patients receiving only palliative care
2. History of pre-existing psychotic disorder, cognitive impairment, delirium or dementia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand spiritual/ religious beliefs of cancer patients when they are undergoing cancer treatment (curative intent) and follow up after completion |
In depth interview at single point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To understand patients’ perspectives on the impact of spiritual/ religious beliefs on their coping with cancer and its treatment
2. To examine the association of religious/spiritual beliefs of cancer patients with socio-demographic factors (age, gender, ethnicity, religious affiliation
|
In depth interview at single point |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2015 |
| Date of Study Completion (India) |
07/07/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Data not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study is to explore the beliefs related to religious and spiritual well being in cancer patients’ undergoing treatment or on follow up after completion of treatment and the impact of religious/ spiritual well being on their coping with cancer and its treatment
OBJECTIVES Primary - To understand religious/spiritual beliefs of cancer patients’ when they are undergoing cancer treatment and follow up after completion Secondary - To understand patients’ perspectives on the impact of religious/spiritual well being on their coping with cancer and its treatment - To examine the association of religious /spiritual beliefs of cancer patients with socio-demographic factors |