Home » Trials » SLCTR/2021/028
Do cancer patients experience less psychological distress with a brief psychological intervention package? : A randomized controlled trial in a selected hospital in Sri Lanka.
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SLCTR Registration Number
SLCTR/2021/028
Date of Registration
The date of last modification
Apr 11, 2023
Scientific Title of Trial
Do cancer patients experience less psychological distress with a brief psychological intervention package? : A randomized controlled trial in a selected hospital in Sri Lanka.
Public Title of Trial
Do cancer patients experience less psychological distress with a brief psychological intervention package compared to routine clinical care?: A randomized controlled trial in a selected hospital in Sri Lanka
Disease or Health Condition(s) Studied
Psychological distress in cancer patients
Scientific Acronym
None
Public Acronym
None
Brief title
Effects of psychological intervention in management of distress in cancer patients
Universal Trial Number
U1111-1269-2819
Any other number(s) assigned to the trial and issuing authority
10/21 (ERC:FMS,USJ)
What is the research question being addressed?
Do cancer patients experience less psychological distress with a brief psychological intervention package compared to routine clinical care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting : A room adjoining the surgical clinic CSTH . Randomization method: The allocation ratio into two arms would be 1:1. Computer-generated random numbers will be used in randomization. Intervention : Control arm Recruitment will be done after one week of breaking bad news at special clinic for cancer patients . 1.Routine care by surgical house officers ,senior registrar is as follow: Explain patients about the surgery, prepare them by doing pre-operative investigations. Referrals to care teams example cardiologist, anaesthetist. Arrange a date for surgery. If patient is refusing his surgery or express depressive symptoms refer to psychiatric care. If patient is not having capacity to consent assessment of capacity to consent by a psychiatrist. No counselling, discussion about their distress is included in routine care. SCREENING AT BASE LINE Eligible patients are assessed using HADS scale (hospital depression anxiety score) after one week of breaking bad news. If they are having high scores 11-21 or severe symptoms which needs psychiatric drugs or psychotherapy, remove from study. Reassessment Week 3 from the baseline Reassessment is done with HADS scale and questionnaire 2.Intervention group BASELINE Eligible patients will be assessed with HADS score if more than 6 will be recruited. If very high scores 11-21 will refer to psychiatric care and if treatment or different psychotherapy is offered they will be removed from the study. Intervention: Session one - First session of the intervention will be done on the day of recruitment, after the baseline assessment. Duration is 2 hours. It is done by a surgical senior registrar and a psychiatrist. 1.Education on cancer: carried out by Senior Registrar in surgery -30 minutes 2.Relaxation training on managing stress response: 30 minute by consultant psychiatrist 3.Problem solving counselling β 1 hour by a Consultant Psychiatrist - a counselling session Session two This will be done after I week from the first session. Duration is two hours . This will be done by the same team and discussion is based on same topics. Post intervention assessment - This will be done three weeks from baseline using HADS and the same questionnaire used in baseline assessment.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Difference in HADS scores . |
[ Before the intervention and 2 weeks after completing the intervention.. ] |
Secondary outcome(s)
1.
Perceptions about - care package received from the hospital by the patient - general well-being - support patients received by the family using an in-house developed questionnaire |
[ 2 weeks after completing the intervention.. ] |
Target number/sample size
82 (41 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2021-10-30
Anticipated end date
2022-04-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funding
Regulatory approvals
Not relevant
Status
Approved
Date of Approval
2021-07-27
Approval number
10/21
Details of Ethics Review Committee
Name: | Ethics Review Committee, University of Sri Jayewardenepura |
Institutional Address: | ERC, Faculty of Medical Sciences, University of Sri Jayewardenepura Gangodawila, Nugegoda, Sri Lanka |
Telephone: | 94-11-2758588, |
Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prasangika Senaviratne Alles
Consultant psychiatrist
Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda
0112802497
+94722319805
dayanip@gmail.com
USJNet Spherehttps://usjnet.sjp.ac.lk
Contact Person for Public Queries
Prasangika Senaviratne Alles
Consultant psychiatrist
Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda
0112802497
+94722319805
dayanip@gmail.com
USJNet Spherehttps://usjnet.sjp.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Data will be shared with All individual data of the participants after de identification. Study protocol, statistical analytic plan will also be shared. Data will be available immediately following publication, no end date. Data will be shared among researchers who provide a methodologically sound proposal in order to achieve the aims in an approved proposal. The proposal should be directed to dayanip@gmail.com. In order to gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results