| CTRI Number |
CTRI/2019/11/022175 [Registered on: 27/11/2019] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study on fatigue, depression and self-esteem among admitted patients with cancer. |
|
Scientific Title of Study
|
Assessment of fatigue, depression and self-esteem among patients undergoing treatment for head and neck cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitin Joseph |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Community Medicine, Kasturba Medical College, Light House Hill Road, Mangalore, Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448732896 |
| Fax |
|
| Email |
drnitinjoseph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Joseph |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Community Medicine, Kasturba Medical College, Light House Hill Road, Mangalore, Karnataka.
KARNATAKA
575001
India |
| Phone |
9448732896 |
| Fax |
|
| Email |
drnitinjoseph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Joseph |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Community Medicine, Kasturba Medical College, Light House Hill Road, Mangalore, Karnataka.
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448732896 |
| Fax |
|
| Email |
drnitinjoseph@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal University Research Grants, Manipal Academy of Higher Education, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal University Manipal Karnataka |
| Address |
Manipal Academy of Higher Education, Madhav Nagar, Manipal 576104. |
| Type of Sponsor |
Private medical 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 |
| Nitin Joseph |
OPD 7, Ward G 1 G, Department of Radiotherapy and Oncology, Kasturba Medical College Hospital |
Attavar, Mangalore
Dakshina Kannada
KARNATAKA |
9448732896
drnitinjoseph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College Mangalore Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, Study group comprised of all incident cases of head and neck squamous cell carcinomas. Control group comprised of out patients at this hospital., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Study group comprised of all incident cases of head and neck squamous cell carcinomas from stage I to stage IV B admitted at Kasturba Medical College hospital, Attavar, Mangalore for radical chemo-radiotherapy.
Control group comprised of out patients without present or past history of cancer.
Only participants aged above 18 years and who gave consent were enrolled in this study by convenience sampling method.
|
|
| ExclusionCriteria |
| Details |
Cases which were very advanced/metastatic, terminally ill, with cognitive impairments and unable to talk were excluded from this study.
Non consenting participants were also excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study was to assess fatigability, depression and self-esteem among head and neck cancer cases before start, during and post cancer chemo radiation therapy period and to find out the determinants of these parameters. |
7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It was also done to find out the determinants of fatigability, depression and self-esteem among these cases. |
7 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2015 |
| Date of Study Completion (India) |
13/12/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: Head and neck cancers (HNC) are one of the most common forms of cancer in India. Patients with this condition often suffers from distressing symptoms of fatigue, depression and poor self-esteem. The exact cause of these symptoms, as to whether disease or other determinants induced or whether treatment induced needs to be established. To assess fatigability, depression and self-esteem among HNC study group before start, during and in the post radiation period and to find out the determinants of these parameters. Materials and methods: Seventy newly diagnosed HNC patients and equivalent number of age and gender matched controls were interviewed using standardized questionnaires, before start of chemo-radiotherapy (CCRT). Study group were interviewed again in the 4th week and post completion of CCRT in the 7th week. Results: Mean age of study group was 55.1± 11.3 years. Three fourth of them 52(74.3%) were males. Majority of them 26(37.1%) had oral cancer. Base line fatigue (p<0.001) and depression scores (p<0.001) were significantly more while self-esteem scores (p=0.004) was significantly less among study group compared to controls before onset of radiation. The mean fatigue and depression scores was found to significantly increase (p<0.001) while self-esteem scores was found to significantly deteriorate (p<0.001) over the course of CCRT among these patients. There was significant positive correlation (p<0.001) between fatigue and depression scores and negative correlation (p<0.001) of these parameters with self-esteem scores before, during and after CCRT. There was no association between age and gender of study group with any of these parameters. Multivariate analysis showed that baseline fatigue was significant probably due to cancer (p<0.001) and depression after completion of entire course of CCRT was significantly influenced by baseline depression levels (p=0.011). Conclusion: Fatigue and depression need to be periodically screened for among HNC study group on CCRT so as to initiate prompt remedial measures for its alleviation. |