| CTRI Number |
CTRI/2026/04/108224 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Therapeutic effect assessment of comprehensive care on routine care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Program for self care management in Multiple Myeloma |
|
Scientific Title of Study
|
A Randomized control trial to assess the effectiveness of Comprehensive Care Intervention Program on Integrated Recovery among patient with Multiple Myeloma at AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hema |
| Designation |
MSc Nursing Student |
| Affiliation |
AIIMS New Delhi |
| Address |
Pota cabin II IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi
Pota cabin II IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7503671837 |
| Fax |
|
| Email |
joshihema28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjwal Dahiya |
| Designation |
Associate Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room Number 4 IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi
Room Number 4 IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9899770134 |
| Fax |
|
| Email |
ujjwaldahiya3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hema |
| Designation |
M Sc Nursing Student |
| Affiliation |
AIIMS Delhi |
| Address |
Pota cabin II IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi
Pota cabin II IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7503671837 |
| Fax |
|
| Email |
joshihema28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Pota cabin II IInd Floor College of Nursing AIIMS Ansari Nagar East New Delhi |
| 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 |
| Hema |
AIIMS new Delhi |
BRAIRCH Medical Oncology OPD AIIMS New Delhi
New Delhi
DELHI |
7503671837
joshihema28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C900||Multiple myeloma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive care intervention program |
A structured nurse led multidimensional intervention delivered at enrollment with subsequent reinforcement at 2 week and 4 week post intervention and post intervention assessment at 6 week through in person sessions through presentation and educative material supplemented by telephonic reinforcement comprising the following integrated components
Systematic education on pain management
Fatigue management through energy conservation activity pacing and sleep hygiene education
Infection prevention education and monitoring
Psychological support for anxiety and depression management |
| Comparator Agent |
Routine care |
Control group receive routine care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years or above with confirmed diagnosis of multiple myeloma
Newly diagnosed patients with multiple myeloma
Receiving outpatient care at AIIMS Delhi
Able to understand and communicate in Hindi or English
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment or diagnosed dementia or Severe psychiatric illness
Currently hospitalized for acute complications at the time of enrollment
Receiving end-of-life care or enrolled in hospice
Previously participated in similar kind of studies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain intensity after using comprehensive care intervention |
Comprehensive care given at the time of enrollment followed by reinforcement at 2 weeks and 4 weeks and assessment at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in fatigue, infection rate, anxiety and depression after using comprehensive care intervention |
Comprehensive care given at the time of enrollment followed by reinforcement at 2 weeks and 4 weeks and assessment at 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
01/08/2026 |
| 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="3"
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
|
This study is a randomized control trial to assess the effectiveness of comprehensive care program intervention on integrated recovery among patient s with multiple myeloma. After screening based on inclusion and exclusion criteria baseline assessment of the participants will be done. Randomization will be done of the enrolled participant into control and experimental group. After randomization control group will receive routine care whereas experimental group will receive comprehensive care intervention along with routine care. Reinforcement of the intervention will be done at 2 week and 4 weeks post intervention. Post intervention assessment will be done at 6 weeks. The findings of this study will help in improving the symptom burden of the disease condition and quality of life of people suffering from multiple myeloma |