Early Palliative Care for Patients with Oral Cancer in Sri Lanka
NCT ID: NCT06726317
Last Updated: 2024-12-10
Study Results
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Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2018-12-15
2020-09-22
Brief Summary
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The primary outcome measures were patient's quality of life and level of psychological distress If there is a comparison group: Researchers compared with a control group who received the standard care to see if the novel early palliative care intervention helped to improve the primary outcomes.
Participants in the intervention arm received the early palliative care package which consisted of 6 components including: 1) providing information, 2) addressing acute and functional issues, 3) nutritional care, 4) psychological support, 5) mindfulness therapy, and 6) coordination of the financial allowance. The intervention was delivered by the Principal Investigator and the trained Public Helath Nursing Officers.
Detailed Description
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Participants The study participants were patients with oral cancer whose definitive diagnosis had been communicated to the patient and had psychological distress (score of ≥4 after screening with the Sinhala version of the Distress Thermometer); awaiting surgery as the first treatment modality; and married with children, including at least one family caregiver with the ability to communicate and read well in Sinhalese. Exclusion criteria were, recurrent oral cancer; a formal psychiatric diagnosis; and receiving or having received any early palliative care intervention. They were divided to 55 controls and 55 cases based on the availability of an accessible Public Health Nursing Officer.
Interventions The early palliative care package, comprising six components, was delivered in three sessions by the principal investigator (PI) and Public Health Nursing Officers.
Outcome measures The effectiveness was assessed by the level of psychological distress using the Sinhala version of the Distress Thermometer and Level of quality of life using EORTC QLQ 30 with module H\&N 35 at baseline (T0), post-intervention (T1), one month (T2), and three months (T3).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group receiving the novel early palliative care package
This group received the novel early palliative care intervention package
Early palliative care integration
The early palliative care intervention package was developed following the guidelines provided by the UK Medical Research Council for the development of complex interventions. The early palliative care intervention for patients with oral cancer had six components: 1) providing information, 2) addressing acute and functional issues, 3) nutritional care, 4) psychological support, 5) mindfulness therapy, and 6) coordination of the financial allowance. The package was formulated by triangulating literature review findings and several independent studies: a case-control study; in-depth interviews with experts in the field of oncology and palliative care in Sri Lanka; key-informant interviews with patients with oral cancer and their caregivers; and an observation study at the National Cancer Institute Sri Lanka- Apeksha Hospital). The intervention package was finalized through a
Control group
This group received only the existing standard care in the health system and did not receive any special intervention through this study
No interventions assigned to this group
Interventions
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Early palliative care integration
The early palliative care intervention package was developed following the guidelines provided by the UK Medical Research Council for the development of complex interventions. The early palliative care intervention for patients with oral cancer had six components: 1) providing information, 2) addressing acute and functional issues, 3) nutritional care, 4) psychological support, 5) mindfulness therapy, and 6) coordination of the financial allowance. The package was formulated by triangulating literature review findings and several independent studies: a case-control study; in-depth interviews with experts in the field of oncology and palliative care in Sri Lanka; key-informant interviews with patients with oral cancer and their caregivers; and an observation study at the National Cancer Institute Sri Lanka- Apeksha Hospital). The intervention package was finalized through a
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of psychological distress (score of ≥4 after screening with the Sinhala version of the Distress Thermometer27)
* awaiting surgery as the first treatment modality
* married with children, including at least one family caregiver with the ability to communicate and read well in Sinhalese.
Exclusion Criteria
* A formal psychiatric diagnosis
* Receiving or having received any early palliative care intervention.
ALL
Yes
Sponsors
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University of Colombo
OTHER
Responsible Party
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Nadisha Ratnasekera
Principal investigator
Principal Investigators
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Irosha Perera, Doctor of Medicine
Role: STUDY_DIRECTOR
Preventive oral Health Unit, National Dental Hospital, Sri Lanka
Pushpakumara Kandapola Arachchige, Doctor of Medicine
Role: STUDY_DIRECTOR
National Cancer Institute, Maharagama- Apeksha Hospital, Sri Lanka
Locations
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Karapitiya Teaching Hospital
Galle, Southern Province, Sri Lanka
National Dental Hospital
Colombo, Western Province, Sri Lanka
Apeksha Hospital
Colombo, Western Province, Sri Lanka
Colombo South (Teaching) Hospital
Colombo, Western Province, Sri Lanka
Countries
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References
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Other Identifiers
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EC-18 097
Identifier Type: -
Identifier Source: org_study_id