| 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
|
|
|
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
|
|
|
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. |