CTRI Number |
CTRI/2023/03/050509 [Registered on: 09/03/2023] Trial Registered Prospectively |
Last Modified On: |
09/03/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Music therapy] |
Study Design |
Single Arm Study |
Public Title of Study
|
study to test the effect of music on quality of life of cancer patients undergoing chemotherapy |
Scientific Title of Study
|
A prospective pilot study to assess the effect of MUSIc therapy on quality of life of Cancer patients undergoing Chemotherapy in Oncology day care - (MUSICC) |
Trial Acronym |
MUSICC |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sujith Kumar Mullapally |
Designation |
Consultant Medical Oncologist |
Affiliation |
Apollo Proton Cancer Centre |
Address |
Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai Chennai TAMIL NADU 600041 India |
Phone |
8547889291 |
Fax |
|
Email |
drsujith_m@apollohospitals.com |
|
Details of Contact Person Scientific Query
|
Name |
Sujith Kumar Mullapally |
Designation |
Consultant Medical Oncologist |
Affiliation |
Apollo Proton Cancer Centre |
Address |
Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai Chennai TAMIL NADU 600041 India |
Phone |
8547889291 |
Fax |
|
Email |
drsujith_m@apollohospitals.com |
|
Details of Contact Person Public Query
|
Name |
Sujith Kumar Mullapally |
Designation |
Consultant Medical Oncologist |
Affiliation |
Apollo Proton Cancer Centre |
Address |
Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai Chennai TAMIL NADU 600041 India |
Phone |
8547889291 |
Fax |
|
Email |
drsujith_m@apollohospitals.com |
|
Source of Monetary or Material Support
|
Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai |
|
Primary Sponsor
|
Name |
Apollo Proton Cancer Centre |
Address |
4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
DIGINXTHLT SOLUTIONS SERVICES Pvt Ltd |
No 422, 9th Main 1st Block, Kalyan Nagar, HRBR Layout, Bengaluru, Bangalore, Karnataka, India, 560043 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Sujith Kumar Mullapally |
Apollo Proton Cancer Centre |
Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai Chennai TAMIL NADU |
8547889291
drsujith_m@apollohospitals.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee - Bio Medical Research, Apollo Hospitals |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Music Therapy |
Sounds rendered by “echo Care†AI based application developed by DigiNxtHlt Solutions and service P Ltd.
The patients will listen to the music/sounds for 30 minutes during each chemotherapy session for 6 weeks |
Comparator Agent |
N/A |
N/A |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
85.00 Year(s) |
Gender |
Both |
Details |
1. Patients with a confirmed diagnosis of cancer undergoing chemotherapy in the daycare facility
2. Patients aged >18 years
3. Patients who are about to start chemotherapy (both curative, palliative intent)
4. Physical condition ( minimum performance status of ECOG 3)
5. Patients with acceptable English comprehension
|
|
ExclusionCriteria |
Details |
1. Patients who have already started chemotherapy
2. Lack of English comprehension as the tools of assessment are validated only in English in the digital platform
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Quality of life |
0,3,6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
predefined health parameters like blood pressure |
0, 3, 6 weeks |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
15/03/2023 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Background and Rationale | People who have cancer may find the physical, emotional, and social effects of the disease to be stressful. Distress has become increasingly recognized as a factor that can reduce the quality of life of cancer patients. Those who are unable to manage their stress may have a poorer quality of life after cancer treatment. In contrast, people who are able to use effective coping strategies to deal with stress have been shown to have lower levels of depression, anxiety, and symptoms related to cancer and its treatment. Music therapy has been extensively used for various conditions related to the mind. However, music preference is very subjective and often rendering music by a performer can be cumbersome, the publicly available music is not designed to cater to the specific needs of the listener or do not have the required calming and therapeutic benefits. Music by ‘echo care’ are engineered at frequencies to render calming effect, improve sleep, elevate mood and reduce stress & anxiety as the case may be. This study is to observe the health benefits of music on the quality of life of the patients. | General aim | The aim of this study is to observe the effects of music therapy and standard care in patients with measured using the EORTC QLQ C30 scale, FACT G7 & HADS before and after the application of music/sound therapy | Primary objective (endpoint) | To evaluate the impact of Music therapy “ on the Quality of life during chemotherapy. . | Secondary objectives (endpoints) | To evaluate the benefits of non-pharmacological, non-invasive, based intervention using echocare music therapy on the anxiety levels and physiological parameters like blood pressure when patients undergo music therapy at start of chemotherapy, during chemotherapy and at the completion of chemotherapy | Design | The study will be conducted at Apollo Proton Cancer Centre at Chennai, India location. A sample size of 50 cancer patients undergoing chemotherapy in the day-care will be part of the study. The age range for this study will be 18 and above. The duration of this study will be for 2 to 3 months. Patient qualification for the study will be done by the attending consultant. The patients will be identified based on their fitment for music therapy which includes physical condition, patient & attendant’s consent and their English language comprehension. | Population | All Genders above the age of 18 undergoing cancer treatment at Apollo proton Chemotherapy Day Care centre | Statistical considerations | To be filled by Dr Pankaj | |