| CTRI Number |
CTRI/2019/09/021057 [Registered on: 04/09/2019] Trial Registered Prospectively |
| Last Modified On: |
03/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [COUNSELLING ON NUTRITION, SWALLOING THERAPY AND HYGEINE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF A COUNSELING AND REHABILITATION PROGRAM ON THE QUALITY OF LIFE OF HEAD AND NECK CANCER PATIENTS UNDERGOING CHEMORADIOTHERAPY
(PILLAR project) |
|
Scientific Title of Study
|
Pilot project to evaluate impact of a patient counselling and rehabilitation programme on treatment outcomes and quality of life in head and neck cancer patients receiving chemoradiotherapy |
| Trial Acronym |
PILLAR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2019-1273 version 08 dated 14/08/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMIT BAHL |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF RADIOTHERAPY
SECTOR 12
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6283774431 |
| Fax |
|
| Email |
dramitbahl@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMIT BAHL |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF RADIOTHERAPY
SECTOR 12
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
PGIMER
SECTOR 12
CHANDIGARH
160012
India |
| Phone |
6283774431 |
| Fax |
|
| Email |
dramitbahl@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AMIT BAHL |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF RADIOTHERAPY
SECTOR 12
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
PGIMER
SECTOR 12
CHANDIGARH
160012
India |
| Phone |
6283774431 |
| Fax |
|
| Email |
dramitbahl@yahoo.com |
|
|
Source of Monetary or Material Support
|
| CONQUER CANCER FOUNDATION OF AMERICAN SOCIETY OF CLINICAL ONCOLOGY USA AND PGIMER CHANDIGARH INDIA |
|
|
Primary Sponsor
|
| Name |
AMERICAN SOCIETY OF CLINICAL ONCOLOGY |
| Address |
2318 MILL ROAD
SUITE 800
ALEXANDRIA VA 22314
USA |
| Type of Sponsor |
Other [ACADEMIC AND RESEARCH ORGANIZATION] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER |
PGIMER
CHANDIGARH,
INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AMIT BAHL |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF RADIOTHERAPY
SECTOR 12
CHANDIGARH INDIA
PIN 160012
Chandigarh
CHANDIGARH |
6283774431
dramitbahl@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COUNSELLING AND SWALLOING THERAPY |
Group A Study group. These patients will receive counselling on nutrition, dysphagia and aspiration prevention, skin care and hygiene, and adopting healthy lifestyle along with standard chemoradiotherapy treatment .
Group B Control group. These patients will receive chemoradiotherapy alone
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients presenting with stage III-IVB head and neck cancers having a histopathological proof and with primaries in oral cavity, oropharynx and hypopharynx will be included in the analysis |
|
| ExclusionCriteria |
| Details |
All post operative patients and those who have undergone prior chemoradiotherapy to head and neck will be excluded from the analysis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the impact of a structured counseling and rehabilitation programme on the quality of life of patients
|
ONE YEAR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the impact of a structured counseling and rehabilitation programme on chemoradiotherapy related treatment toxicity
2.To evaluate the impact of a structured counseling and rehabilitation programme on patients compliance to treatment
|
ONE YEAR |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/09/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this research is to evaluate a dedicated & comprehensive supportive care and rehabilitation programme for patients with locally advanced head and neck cancers receiving chemoradiotherapy. Our hypothesis is based on the assumption that integrating counseling and rehabilitation services with the treatment will improve patient compliance and tolerance to chemoradiotherapy and will positively impact the treatment outcomes and quality of life of the patients. Dedicated faculty will monitor the patients during the project and provide counseling on hygeine , nutrition, home made diets and swallowing therapy to prevent dysphagia. The aims and objectives of this study are as below
1.
To evaluate the
impact of a structured counseling and rehabilitation programme on the quality
of life of patients
2. To evaluate the
impact of a structured counseling and rehabilitation program on
chemoradiotherapy related treatment toxicity
3. To evaluate the
impact of a structured counseling and rehabilitation programme on patients
compliance to treatment
Majority of our patients come from the economically weaker sections of society and are unaware of and also unable to afford dedicated supportive services.The research is designed to fill this lacunae in our patient care system for such patients.
Head and neck cancers is emerging as a important public health problem in our country with a huge burden of disease( 30% cancers in males and 4.8-15% cancers in females). The results of this study will help us improve our treatment protocols keeping in mind the specific requirements of our Indian patients and we propose to provide counselling and rehabilitation services routinely to our patients in the near future by using the results of this pilot project to guide us. |