| CTRI Number |
CTRI/2025/02/081456 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Psychological Intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Supportive Psychotherapy on self-esteem and coping skills among patients with oral cancer |
|
Scientific Title of Study
|
A Randomized Controlled Trial on Efficacy of Supportive Psychotherapy on self-esteem and coping skills among patients with oral cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayesha Patel |
| Designation |
MPhil Clinical Psychology Trainee |
| Affiliation |
Amity University Uttar Pradesh |
| Address |
Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University Lucknow Campus, Malhour
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9594959065 |
| Fax |
|
| Email |
ayeshapatel98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anamika Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Uttar Pradesh |
| Address |
Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University Lucknow Campus, Malhour
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9682401111 |
| Fax |
|
| Email |
anamika.cp.lucknow@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anamika Srivastava |
| Designation |
Assistant Professor |
| Affiliation |
Amity University Uttar Pradesh |
| Address |
Department of Clinical Psychology, Amity Institute of Behavioural and Allied Sciences (AIBAS), Amity University Lucknow Campus, Malhour
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9682401111 |
| Fax |
|
| Email |
anamika.cp.lucknow@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalyan Singh Super Specialty Cancer Institute
Department of Head & Neck (OMFS), C.G. City, Sultanpur Road, Lucknow - 226002, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Ayesha Patel |
| Address |
AIBAS, Amity University Lucknow Campus, Malhour, Lucknow, Uttar Pradesh - 226010 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Gaurav Singh |
Kalyan Singh Super Specialty Cancer Institute |
Department of Head & Neck (OMFS), C.G. City, Sultanpur Road, Lucknow - 226002
Lucknow
UTTAR PRADESH |
9582702763
drgaurav2@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 |
Supportive Psychotherapy |
A therapeutic intervention aimed at providing psychological support by helping patients with oral cancer improve self-esteem and enhance coping skills. It will be delivered over 6 weekly sessions. |
| Comparator Agent |
Treatment as usual |
Participants in this group will receive standard care required for their diagnosis with supplementary educational content on cancer biology for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Diagnosed between stage II to IV cancer and in active treatment phase
-Patients who consent to participate in psychotherapy
-Those giving written informed consent
|
|
| ExclusionCriteria |
| Details |
-Patients with severe neurological, psychiatric or cognitive impairments that require immediate psychiatric intervention or hospitalization or precludes meaningful participation in psychotherapy
-Those receiving any other form of structured psychotherapy for the past 3 months
-Uncooperative patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in the scores of Rosenberg Self-esteem Scale and adaptive coping of Stress Coping Behaviour Scale |
At Baseline (Week 0) and Two weeks after completion of intervention (Week 8) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in maladaptive coping |
At Baseline (Week 0) & Two weeks after completion of intervention (Week 8) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The primary purpose of this randomized controlled trial is to evaluate the efficacy of a 6-week supportive psychotherapy intervention in improving self-esteem and coping skills among patients between stages II to IV oral cancer. The intervention aims to provide emotional support, enhance adaptive coping strategies and self esteem, and improve psychological well-being, complementing standard cancer treatment. The study hypothesizes that supportive psychotherapy, in addition to treatment as usual (TAU), will result in significant improvements in self-esteem and coping skills compared to TAU alone. |