| CTRI Number |
CTRI/2025/08/092544 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NCCN Distress Thermometer and problem list] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Helping Cancer Patients Feel Better: Testing Stress Checks and Tailored Support During Radiotherapy. |
|
Scientific Title of Study
|
A Randomised Single Blinded Trial Assessing the Impact of Routine Distress Screening and Personalised Interventions on Quality of Life and Distress in Cancer patients Undergoing Radiotherapy. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mouchumee Bhattacharyya |
| Designation |
Prof. and In charge Dept. of Radiation Oncology and Dy. Director of Research, BBCI |
| Affiliation |
Dr. B. Borooah Cancer Institute |
| Address |
Dr. B. Borooah Cancer Institute, Department of Radiation Oncology, Room No-10, Gopinath Nagar, A K Azad Road, Guwahati-781016,
Assam, India
Kamrup
ASSAM
781016
India |
| Phone |
9435111799 |
| Fax |
|
| Email |
mouchumee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tapashi Das |
| Designation |
Senior Resident, Radiation Oncology, Dr. B. Borooah Cancer Institute |
| Affiliation |
Dr. B. Borooah Cancer Institute |
| Address |
Dr. B. Borooah Cancer Institute, Radiation Oncology room no. 110 Gopinath Nagar, A K Azad Road, Guwahati-781016,
Assam, India
Kamrup
ASSAM
781016
India |
| Phone |
6000718754 |
| Fax |
|
| Email |
dastapsee02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tapashi Das |
| Designation |
Senior Resident, Radiation Oncology, Dr. B. Borooah Cancer Institute |
| Affiliation |
Dr. B. Borooah Cancer Institute |
| Address |
Dr. B. Borooah Cancer Institute, Radiation Oncology room no. 110, Gopinath Nagar, A K Azad Road, Guwahati-781016,
Assam, India
Kamrup
ASSAM
781016
India |
| Phone |
6000718754 |
| Fax |
|
| Email |
dastapsee02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mouchumee Bhattacharyya |
| Address |
Dr. B. Borooah Cancer Institute, Department of Radiation Oncology, Room No-10, Gopinath Nagar, A K Azad Road, Guwahati-781016,
Assam, India |
| 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 |
| Dr Mouchumee Bhattacharyya |
Dr. B. Borooah Cancer Institute |
Radiation Oncology room no. 10, ground floor.
Kamrup
ASSAM |
9435111799
mouchumee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NCCN Distress Thermometer and problem list |
Arm A (Intervention group) Patients will
undergo routine distress screening using the
NCCN Distress Thermometer (DT) and Problem
List prior to the start of radiotherapy. Following
this, screening will be done weekly until the
distress score reaches greater than or equal to 5. If the patients distress
score is greater than or equal to 5, additional interventions (e.g., social
work and counselling services, psychological
support, palliative care, patient navigation
support) will be offered as appropriate. After the
distress score reaches greater than or equal to 5, subsequent distress
screening will be conducted at the end of
treatment to assess any changes and ensure that
the patient’s needs are addressed appropriately.
If the distress score remains below 5, routine
weekly screenings will continue until the
completion of radiotherapy. QOL will be assessed at beginning and end of radiotherapy using a
validated QOL tool EORTC QLQ-C30. |
| Comparator Agent |
Standard care |
Arm B (Control group) Patients will receive
standard care, which includes medical treatment
without systematic distress screening. The control
group will only receive psychosocial support if
requested or as clinically indicated by healthcare
providers. QOL will be assessed at beginning and
end of radiotherapy using the same validated tool
EORTC QLQ-C30. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
81.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed cancer patients planned
for definitive or upfront radiotherapy or
chemoradiotherapy at Dr B Borooah
Cancer Institute.
2. Performance Status: ECOG Performance
Status of 0-2
3. Patients must be willing to provide
informed consent for participation in the
study. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
o ECOG Performance Status greater than or equal to 3.
o Age less than or equal to 18 years.
o Diagnosis of depression or mood
disorder, and patients on antidepressants
and anti-psychotics from before
o Patients who have previously undergone
neoadjuvant chemotherapy, surgery, or
radiotherapy.
o Treated with palliative intent.
o Patients who do not provide informed
consent to participate in the study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anticipating that routine distress screening and timely interventions will significantly reduce the
psychological and practical challenges faced by cancer patients. |
At the start of radiotherapy, weekly and at the end of radiotherapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Factors influencing distress among
patients will be identified which will help us to develop prophylactic measures for these group of patients
upfront. |
At the start of radiotherapy, weekly and at the end of radiotherapy. |
Additionally, expecting to see improved quality of life scores in the screening group compared
to the standard care group. |
QOL will be assessed at beginning and end of radiotherapy using
a validated QOL tool EORTC QLQ-C30 in both the arms. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dastapsee02@gmail.com].
- For how long will this data be available start date provided 19-08-2025 and end date provided 18-08-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective, single-institution, randomized controlled study aims to evaluate the impact of routine distress screening using the NCCN Distress Thermometer and Problem List, followed by tailored interventions, on quality of life (QoL) and psychological distress in cancer patients undergoing definitive radiotherapy at Dr. B. Borooah Cancer Institute, Guwahati. Two groups will be studied Arm A (Intervention) Patients will undergo weekly distress screening. If distress scores are greater than or equal to 5, timely psychosocial and supportive interventions will be provided. Arm B (Control) Patients will receive standard care without routine distress screening, with support offered only if requested or deemed necessary by clinicians. QoL will be assessed in both groups at baseline and at the end of treatment using the EORTC QLQ-C30 tool. The primary objective is to assess the effectiveness of distress screening and intervention in reducing distress; secondary objectives include identifying common causes of distress and comparing QoL between groups. A total of 200 patients (100 per group) will be recruited through purposive and stratified random sampling based on cancer type using random number table. The estimated statistical power is 90%, and data will be analyzed using appropriate statistical tests in RStudio or SPSS. Psychosocial adverse events will be monitored throughout. Expected outcomes include reduced distress levels, improved QoL, and identification of common distress factors. If effective, the study will support integrating routine distress screening into standard cancer care protocols, possibly through EMR systems. Limitations include single-center bias and absence of long-term follow-up. Future plans involve multicentric validation and long-term impact assessment. Study duration Nearly 18 months including recruitment, intervention, follow-up, and analysis. |