| CTRI Number |
CTRI/2025/09/094852 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Journaling] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Journaling and its impact on the quality of life of adolescents and young adults receiving palliative care |
|
Scientific Title of Study
|
Effect of journaling on person-centric outcomes in adolescents and young adults receiving specialist palliative care: a randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aby John Thampi |
| Designation |
Postgraduate Student |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Palliative Medicine, Christian Medical College Vellore, Ida Scudder Road, 632004
Christian Medical College Vellore, Ida Scudder Road, 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
7012476378 |
| Fax |
|
| Email |
abyjohn.thambi.pg@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Jenifer Jeba S |
| Designation |
Professor and Head |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Palliative Medicine, Christian Medical College Vellore, Ida Scudder Road, 632004
Christian Medical College Vellore, Ida Scudder Road, 632004
Vellore
TAMIL NADU
632004
India |
| Phone |
9360647948 |
| Fax |
|
| Email |
jenifer.jeba@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Aby John Thampi |
| Designation |
Postgraduate Student |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Palliative Medicine, Christian Medical College Vellore, Ida Scudder Road, 632004
Christian Medical College Vellore, Ida Scudder Road, 632004
TAMIL NADU
632004
India |
| Phone |
7012476378 |
| Fax |
|
| Email |
abyjohn.thambi.pg@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore, Ida Scudder Road, Vellore, Tamil Nadu, India - 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College Vellore, Ida Scudder Road, 632004 |
| Type of Sponsor |
Private medical college |
|
|
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 Aby John Thampi |
Christian Medical College Vellore |
Office-Department of Palliative Medicine, O Block, 3rd floor, Christian Medical College Vellore, Ida Scudder Road, 632004
Vellore
TAMIL NADU |
7012476378
abyjohn.thambi.pg@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
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 |
Journaling |
Total Duration: 1 month. The intervention involves guided journaling in which participants use a structured
template with prompts to write about their feelings and unspoken thoughts regarding
their illness, significant life events, positive experiences (past or present), personal
priorities and aspects of life that they are grateful for. Journaling has its roots in positive psychology and narrative therapy and has been studied extensively in cancer population where it has been found to improve the wellbeing of patients.Previous studies in patients with cancer have used various techniques for journaling such as expressive
writing, reflective journaling and mindful gratitude journaling.However, none of the
techniques focused on AYAs as the population. We chose a blended journaling method
guided by prompts keeping in mind the socioeconomic, cultural and educational
contexts of AYAs in our setting, most of them still being dependent on their
parents/families, are not fully disclosed about the diagnostic/prognostic implications
and to avoid any emotional strife during the process of journaling.
Participants will be provided a physical journal (A5 sized diary) for journaling and will
be provided a template of prompts, in a language they can comprehend, in the form of
open-ended questions to serve as a guide in the process. They will be asked to write for
a minimum of 10-15 minutes/day, for at-least 3 times a week, for one month. It can be
done in the place of their choice and comfort and written in a language that they are
familiar with. Initial demonstration (lasting about 5 - 10 minutes) will be provided by
research coordinators to ensure comprehension. Patients will receive regular telephonic reminders on journaling. Moreover, they will be asked to tick a checkbox at the bottom of the template page after they finish the day’s journaling. The content of journal will remain with the participant and need not be shared with the researchers unless the participant wishes to. The hard copy of journals can be kept securely with participant or may even be disposed post the intervention (if the participant wishes to. At T1 (day 7) and T2 (end of one month), a follow-up (telephonic or face-to-face) will be done to assess quality-of-life and psychological distress using FACIT-Sp and HADS respectively.In addition, the intervention group (Arm A) will continue to receive the usual care
measures in the form of standard multidisciplinary palliative care services based on patient and caregiver needs from palliative medicine specialist, nurse, psychologist and social worker. The multi-disciplinary palliative care team will provide care based on patient and caregiver needs and will not be informed of the participant’s allocation arm, although it may become evident as part of routine interaction. |
| Comparator Agent |
Usual care alone (need-based comprehensive multidisciplinary palliative care services from palliative medicine specialist, nurse, psychologist and social worker.) |
The control group (Arm B) will receive the usual care alone, i.e., need-based comprehensive multidisciplinary palliative care services from palliative medicine specialist, nurse, psychologist and social worker. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
- Diagnosis of advanced cancer, i.e., any solid or hematological malignancy unlikely
to be cured or controlled with treatment.
- AYAs who are physically able and have the cognition to be able to think, reflect
and write.
- Able to read and write in a language they are familiar with. |
|
| ExclusionCriteria |
| Details |
1. Cognitive impairment, confusion, or delirium prohibiting reliable self-report.
2. Sensorimotor deficits preventing participation.
3. Severe comorbid psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the change in patient’s quality of life from baseline to
day 7 between intervention arm and control arm as measured on the Functional Assessment of Chronic Therapy - Spiritual Well-being (FACIT-Sp) |
At Baseline (T0) & At 1 week (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the change in patient’s quality of life from baseline to one month between intervention arm and control arm as measured on
the Functional Assessment of Chronic Therapy - Spiritual Well-being (FACIT-Sp). |
T0-Day 0, T2-At one month |
| Compare the change in patients’ psychological distress from baseline to day 7 between intervention arm and control arm as measured on Hospital Anxiety and Depression Scale-Anxiety and Depression {HADS (A & D)} scores. |
T0-Day 0, T1-Day 7 |
Compare the change in patients’ psychological distress from baseline
to one month between intervention arm and control arm as measured on Hospital Anxiety and Depression Scale-Anxiety and Depression {HADS (A & D)} scores. |
T0-Day 0, T2-At One Month |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
06/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Adolescents and Young Adults (AYAs) with advanced cancer face profound physical, psychological, and existential distress during a critical developmental stage, compounded by unmet psychosocial needs. In resource-limited settings like India, where specialist palliative care is scarce and culturally tailored interventions for AYAs are lacking, scalable, low-cost solutions are urgently needed. Guided journaling is a promising yet understudied approach to address this gap. This randomized controlled trial evaluates the effect of guided journaling on person-centric outcomes among adolescents and young adults (AYAs; aged 15–39 years) with advanced cancer receiving specialist palliative care at Christian Medical College, Vellore, India. Participants (n=82) are randomized 1:1 to either a guided journaling intervention (at-least three times a week, for a month using structured prompts focused on emotional processing, gratitude, and coping) alongside usual palliative care or to usual palliative care alone. The outcomes assessed will be changes in quality of life and psychological distress, measured using validated tools at baseline and post intervention. In addition, qualitative interviews will be conducted with a subset of participants to explore their perceptions of journaling, including its emotional impact, acceptability, and perceived benefits or challenges. This mixed-methods approach aims to provide a holistic understanding of how journaling may support psychological wellbeing in AYAs facing serious illness. This study aims to address an important gap in the availability of low-cost, scalable, and culturally appropriate psychosocial interventions for AYAs in low-resource settings. Findings from this trial have the potential to inform future palliative care practices and guidelines in low- and middle-income countries (LMICs), where specialist psychological support is often limited. By centering the voices and experiences of young people in palliative care, the study contributes to a growing emphasis on person-centered, age appropriate, and holistic care models. |