Clinical trial NCT06726317: Early Palliative Care for Patients with Oral Cancer in Sri Lanka
Official title: The Prevalence and Associated Factors of Psychological Distress, and Effectiveness of a 'life Situation Improving Intervention' Among Oral Cancer Patients Attending Tertiary Care Hospitals in the Colombo District
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Palliative Supportive Care
Psychological Distress
Quality of Life of Patients
Keywords: early palliative care interventions
oral cancer
head and neck cancer
quality-of-life
psychological distress
supportive care
mindfulness therapy
Lead sponsor: University of Colombo
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a Quasi Experimental study with a parallel control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this quasi experimental study is to develop and assess the effectiveness of an early palliative care intervention in patients with oral cancer in Sri Lanka. The main question it aims to answer is whether the early palliative care intervention improves the quality of life and psychological distress of patients with cancer in Sri Lanka.

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: The study took place at three tertiary care units providing oral cancer treatment in Sri Lanka: the oral and maxillofacial wards at the National Dental Hospital, Colombo (Teaching); the oral and maxillofacial wards at Colombo South (Teaching) Hospital, Karapitiya; and the onco-surgery wards at the National Cancer Institute Maharagama (Apeksha Hospital).

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).

Eligibility criteria: Inclusion Criteria:

* Definitive diagnosis communicated to the patient
* 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:

* Recurrent oral cancer
* A formal psychiatric diagnosis
* Receiving or having received any early palliative care intervention.

Primary outcomes:
measure: Patient's quality of life
timeFrame: This outcome measure was collected at four-time points: at enrollment, immediately after delivering the intervention package, 1 month after and three months after the intervention.
measure: Patient's level of psychological distress
timeFrame: The outcome measures were collected at four-time points: at enrollment, immediately after delivering the intervention package, one month and three months after the intervention.
measure: Patient's quality of life related to the Head and Neck condition
timeFrame: This outcome measure was collected at four-time points: at enrollment, immediately after delivering the intervention package, 1 month after and three months after the intervention.
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: This was measured 3 months after the delivery of the intervention package
Other outcomes:
Locations:
city: Galle
country: Sri Lanka
facility: Karapitiya Teaching Hospital
state: Southern
city: Colombo
country: Sri Lanka
facility: National Dental Hospital
state: Western
city: Colombo
country: Sri Lanka
facility: Apeksha Hospital
state: Western
city: Colombo
country: Sri Lanka
facility: Colombo South (Teaching) Hospital
state: Western
Study officials:
affiliation: Preventive oral Health Unit, National Dental Hospital, Sri Lanka
name: Irosha Perera, Doctor of Medicine
role: STUDY_DIRECTOR
affiliation: National Cancer Institute, Maharagama- Apeksha Hospital, Sri Lanka
name: Pushpakumara Kandapola Arachchige, Doctor of Medicine
role: STUDY_DIRECTOR
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