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

14 Oct 2021

The date of last modification

Apr 11, 2023



Application Summary


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)


Trial Details


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 – 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

  1. Patients with new/ recent histopathological diagnosis /radiological diagnosis of a malignant lesion of any site
  2. Age between 18-65 years
  3. Both male and female patients 4.Cancer stage which is eligible for surgery as determined by investigation procedures and clinical judgment
  4. Patients who are having HADS score more than > 6 will be recruited to the study

Exclusion criteria

  1. Patients with already diagnosed psychiatric disorders (with a diagnosis of any one or more conditions specified under F00-F99 under ICD diagnosis research version (β€˜The ICD-10’, no date).
  2. Patients with severe physical suffering and who are unwell to communicate or travel.
  3. Patients who are diagnosed/carrying a card or past records with a severe learning disability, organic brain dysfunction due to cerebral deposits, diagnosed patients with dementia will not be recruited to the study) the research assistants will be trained for this using ICD diagnostic criteria for the research version.
  4. Patients who are participating in other interventional studies.
  5. Patients who are coming more than one week after breaking bad news.
  6. Patients who are having HADS SCORE less than 6


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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Faculty of Medical Sciences, USJ





Secondary study sponsor (If any)

None





Trial Completion details


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