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CTRI Number  CTRI/2025/03/082123 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 15/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Enhancing Cancer Quality of Life of cancer patient and caregiver 
Scientific Title of Study   Implementing Communication Strategies to Improve the Quality of Life of Cancer Survivors and Caregivers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Shankar  
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Room No. 143, First Floor, Department of Radiation Oncology
Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India 
Phone  9968721213  
Fax    
Email  doc.abhishankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhishek Shankar  
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Room No. 143, First Floor, Department of Radiation Oncology
Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi

DELHI
110029
India 
Phone  9968721213  
Fax    
Email  doc.abhishankar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abhishek Shankar  
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Room No. 143, First Floor, Department of Radiation Oncology
Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi

DELHI
110029
India 
Phone  9968721213  
Fax    
Email  doc.abhishankar@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Shankar   All India Institute of Medical Sciences, Delhi, India  Room No. 59, DRBRAIRCH, All India Institute of Medical Sciences, Delhi, India
South
DELHI 
9968721213

doc.abhishankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  symptom management toolkit (SMT)  printed symptom management toolkit (SMT) with strategies for self-management of symptoms common during radiotherapy and/or chemotherapy will be given to both survivor and caregiver (the dyad). SMT alone stepped up with TIP-C based on demonstrated needs after giving SMT alone 4 weeks of time, If the survivor’s depression or anxiety does not respond to SMT alone at week 4,dyads will be re-randomized to the TIP- C+SMT or continue with SMT alone. 
Comparator Agent  symptom management toolkit (SMT) + telephone interpersonal counseling intervention (TIP-C)  combined TIP-C+SMT for the first 8 weeks then SMT alone for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for cancer survivor
1. age 18 or older
2. undergoing chemotherapy, hormonal therapy, or
targeted therapy for a solid tumor cancer
3. able to perform basic activities of daily living
4. cognitively oriented to time, place, and person
(determined by recruiter)
5. reporting severity of more than 2 on depression or more than 4 on anxiety using a 0-10 standardized scale
6. able to speak and understand English or Hindi
7. access to a telephone
8. has a caregiver who can be in any relationship role e.g., spouse, sibling, parent, friend, who can
participate with them.

for cancer caregiver
1.able to speak and understand English or Spanish
2. access to a telephone
3. not currently receiving counseling and/or
psychotherapy
4. not currently treated for cancer 
 
ExclusionCriteria 
Details  diagnosis of a psychotic disorder in the health record;
nursing home resident;
bedridden;
currently receiving counseling and/or psychotherapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Symptom Severity Index- Comparison of Two Groups Created by First Randomization at weeks 1-13 and week 17 using the modified General Symptom Distress Scale (GSDS).
2. Symptom Severity Index- Comparison of Two Groups Created by Second Randomization at weeks 5-13 and per week using the modified General Symptom Distress Scale (GSDS).
3. Change in Number and Distress Associated with Caregivers and Survivors Symptoms weekly for 13 weeks and follow-up at 17 weeks 
1. 1-13 week, 17 week
2. 5-13 weeks and per week
3. weekly 13 week, 17 week 
 
Secondary Outcome  
Outcome  TimePoints 
Depressive Symptoms- Comparison of Two Groups Created by First Randomization at week 13
and week 17 using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. 
13 week, 17 week 
Depressive Symptoms- Comparison of Two Groups Created by Second Randomization at week
13 and week 17 using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. 
13 week, 17 week 
Anxiety Symptoms- Comparison of Two Groups Created by First Randomization at week 13 and
week 17 using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety
8a short form. 
13 week, 17 week 
Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization at week 13 and
week 17 using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a
short form. 
13 week, 17 week 
Change in Hospitalizations, provider visits, urgent care or Emergency Department visits at baseline,
week 13, 17) 
0 week, 13 week, 17 week 
Change in Depression and Anxiety of Survivor and Caregiver at baseline, week 13, 17) using Patient
Reported Outcomes Information System (PROMIS) depression and anxiety 8 item short form scales. 
0 week, 13 week, 17 week 
Change in Survivor and Caregiver Self-Efficacy at baseline, week 13, 17) using PROMIS Self-Efficacy
for managing symptoms-sf4a. 
0 week, 13 week, 17 week 
Change in Survivor and Caregiver Social Support at baseline, weeks 13, 17) using PROMIS
Informational and Emotional Support-8 item short forms. 
0 week, 13 week, 17 week 
Change in Caregiver Reactions at baseline, weeks 13, 17 using Caregiver Reaction Assessment Tool.  0 week, 13 week, 17 week 
 
Target Sample Size   Total Sample Size="298"
Sample Size from India="298" 
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)   01/04/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
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 - NO
Brief Summary  
Caregivers, typically family members or friends, provide more than half of the care needed for cancer survivors, often with negative health consequences. At least 30% of survivors and their caregivers report psychological distress (depression and anxiety) and such distress may interfere with optimal symptom management. This study will support both members of the survivor-caregiver dyad in the management of the survivor’s cancer- and treatment-related symptoms and the dyad’s psychological distress. There are no such studies reported from India on the integration of two potentially synergistic interventions, SMT, and TIP-C to achieve outcomes that are better than a simple sum of the two because, as argued under the scientific premise. SMART design will be used for this study over alternative designs (e.g., implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. The objectives of this study are to determine if dyads in the TIP- C+SMT as compared to the SMT alone will have lower depression, anxiety, and summed severity of 13 other symptoms, lower use of healthcare services (hospitalizations, and emergency care), greater self-efficacy, social support, and lower caregiver burden. It will also test the interdependence in survivor’s and caregiver’s primary and secondary outcomes.
We will use two evidence-based interventions: Symptom Management Toolkit (SMT) and Telephone Interpersonal Counseling (TIP-C). Although we have established the overall efficacy of these interventions, individuals differ in responses. We will enroll 298 survivors with elevated depression or anxiety who are undergoing radiotherapy, chemotherapy, or targeted therapy for a solid tumor and their 298 caregivers. Dyads will be initially randomized to SMT alone or TIP-C +SMT. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Assessments during weeks 1-12 will document changes in symptoms, intervention receipt, enactment, and fidelity. Caregivers’ and survivors’ symptoms will be measured using the adapted General Symptom Distress Scale (GSDS). Caregivers’ and survivors’ depression and anxiety, self-efficacy, and social support will be measured by PROMIS-short forms 8. Findings will be used to improve symptom management and reduce distress in survivor-caregiver dyads.
 
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