Oral CancerNCT06726317
Early Palliative Care For Patients With Oral Cancer in Sri Lanka
A study testing Early palliative care integration in people with Oral Cancer and Palliative Supportive Care, run by University of Colombo at 4 sites in Sri Lanka.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer, Palliative Supportive Care, Psychological Distress
- What is being tested?
- Early palliative care integration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesSri Lanka
- Study dates
- 15 Dec 2018to 22 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Recurrent oral cancer
- A formal psychiatric diagnosis
- Receiving or having received any early palliative care intervention.
Trial locations and contacts
4 sites in 1 country.
Sri Lanka4 sites
National Dental Hospital
Colombo, Western Province, 0007
Apeksha Hospital
Colombo, Western Province
Colombo South (Teaching) Hospital
Colombo, Western Province
Karapitiya Teaching Hospital
Galle, Southern Province
About this study
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
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.
Read the 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).
- Conditions
- Oral Cancer, Palliative Supportive Care, Psychological Distress, Quality of Life of Patients
- Being tested
- Early palliative care integration
- Keywords
- early palliative care interventions, oral cancer, head and neck cancer, quality-of-life, psychological distress, supportive care, mindfulness therapy
- Medical subject headings
- Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative care integrationBehavioural
Also called Supportive care, Psycho-oncology care
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group receiving the novel early palliative care package | Experimental | This group received the novel early palliative care intervention package Receives: Behavioral: Early palliative care integration |
| Control group | No intervention | This group received only the existing standard care in the health system and did not receive any special intervention through this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's quality of life
Quality of life was measured using the Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (version C30) -EORTC QLQ 30. This tool was translated and validated to Sri Lanka through a large-scale multi-centre study. This tool measured quality of life in three sub dimensions-Global Health Status, Functional Scale and Symptom Scale. a high score in Global Health Status denoted a high quality of life, a high score for Functional Scale meant healthy level of functioning and a high score in Symptom Scale represented high level of problems
Measured: 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.
Patient's level of psychological distress
The level of psychological distress was measured through the mean scores of the Sinhala version of the Distress Thermometer. The Distress Thermometer is 1 item, an ultra-short, visual analogue screening tool, originally developed in the America for prostate cancer patients in 1998. The Distress Thermometer comes with a Problem List. This has 35 items and it covers 5 life domains (practical, family/social, emotional, spiritual, and physical problems). The Distress Thermometer and Problem List were translated into the Sinhala language (the primary language in Sri Lanka) and cross-culturally adapted to Sri Lanka.
Measured: 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.
Patient's quality of life related to the Head and Neck condition
This was measured using Head \& Neck-35 module (H\&N-35) by European Organization for Research and Treatment of Cancer. This tool was translated and validated to Sri Lanka through a large-scale multi-centre study. A high score in H\&N-35 module also meant high level of problems whcih meant low quality of life.
Measured: 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 (1)
Patient's satisfaction
Patient's satisfaction with the novel intervention was measured using a validated questionnaire.
Measured: This was measured 3 months after the delivery of the intervention package
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start15 Dec 2018
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This was a Quasi Experimental study with a parallel control group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colombo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadisha Ratnasekera, University of Colombo
- Investigators
- Irosha Perera, Doctor of Medicine, Study director, Preventive oral Health Unit, National Dental Hospital, Sri LankaPushpakumara Kandapola Arachchige, Doctor of Medicine, Study director, National Cancer Institute, Maharagama- Apeksha Hospital, Sri Lanka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726317
- Sponsor's protocol ID
- EC-18 097
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be required at any level for any purpose. Also, keeping to the ethical conduct- I am obliged to protect the confidentiality of the participants. Therefore, as ICP serve no good purpose I will not share them
Publications
Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.
PubMed 14705607Kadan-Lottick NS, Vanderwerker LC, Block SD, Zhang B, Prigerson HG. Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the coping with cancer study. Cancer. 2005 Dec 15;104(12):2872-81. doi: 10.1002/cncr.21532.
PubMed 16284994Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.
PubMed 1609875Jayasekara H, Rajapaksa LC, Aaronson NK. Health-related quality-of-life in patients with head-and-neck cancer in Sri Lanka: psychometric properties of the 'Sinhala' version of the EORTC QLQ-H&N35. Psychooncology. 2009 Oct;18(10):1116-21. doi: 10.1002/pon.1430.
PubMed 19142857Jayakar R, Choi J, MacKinnon C, Tan S. The cost of major head and neck cancer surgery. N Z Med J. 2017 May 12;130(1455):111-119.
PubMed 28494483Jacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16.
PubMed 18558664Ip WY, Martin CR. Psychometric properties of the 12-item General Health Questionnaire (GHQ-12) in Chinese women during pregnancy and in the postnatal period. Psychol Health Med. 2006 Feb;11(1):60-9. doi: 10.1080/13548500500155750.
PubMed 17129895Infurna FJ, Gerstorf D, Ram N. The nature and correlates of change in depressive symptoms with cancer diagnosis: reaction and adaptation. Psychol Aging. 2013 Jun;28(2):386-401. doi: 10.1037/a0029775. Epub 2012 Sep 17.
PubMed 22984800Hutchison SD, Steginga SK, Dunn J. The tiered model of psychosocial intervention in cancer: a community based approach. Psychooncology. 2006 Jun;15(6):541-6. doi: 10.1002/pon.973.
PubMed 16331595van den Hurk DG, Schellekens MP, Molema J, Speckens AE, van der Drift MA. Mindfulness-Based Stress Reduction for lung cancer patients and their partners: Results of a mixed methods pilot study. Palliat Med. 2015 Jul;29(7):652-60. doi: 10.1177/0269216315572720. Epub 2015 Feb 20.
PubMed 25701663Humphris GM, Ozakinci G. Psychological responses and support needs of patients following head and neck cancer. Int J Surg. 2006;4(1):37-44. doi: 10.1016/j.ijsu.2005.12.004. Epub 2006 Feb 3.
PubMed 17462312Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
PubMed 472086Hopko DR, Bell JL, Armento M, Robertson S, Mullane C, Wolf N, Lejuez CW. Cognitive-behavior therapy for depressed cancer patients in a medical care setting. Behav Ther. 2008 Jun;39(2):126-36. doi: 10.1016/j.beth.2007.05.007. Epub 2007 Oct 31.
PubMed 18502246Hong JS, Tian J. Sensitivity and specificity of the Distress Thermometer in screening for distress in long-term nasopharyngeal cancer survivors. Curr Oncol. 2013 Dec;20(6):e570-6. doi: 10.3747/co.20.1617.
PubMed 24311958Holtedahl K, Norum J, Anvik T, Richardsen E. Do cancer patients benefit from short-term contact with a general practitioner following cancer treatment? A randomised, controlled study. Support Care Cancer. 2005 Nov;13(11):949-56. doi: 10.1007/s00520-005-0869-5. Epub 2005 Jul 16.
PubMed 16025260
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06726317
- Acronym / sponsor ID
- EC-18 097
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ColomboUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a Quasi Experimental study with a parallel control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group receiving the novel early palliative care package | Experimental | Behavioral: Early palliative care integrationThis group received the novel early palliative care intervention package |
| Control group | No intervention | –This group received only the existing standard care in the health system and did not receive any special intervention through this study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Recurrent oral cancer
- A formal psychiatric diagnosis
- Receiving or having received any early palliative care intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early palliative care integrationAlso: Supportive care, Psycho-oncology careThe 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 | Behavioural | Intervention group receiving the novel early palliative care package |
Primary outcome
Patient's quality of life
Time frame: 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.
Quality of life was measured using the Sinhala version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (version C30) -EORTC QLQ 30. This tool was translated and validated to Sri Lanka through a large-scale multi-centre study. This tool measured quality of life in three sub dimensions-Global Health Status, Functional Scale and Symptom Scale. a high score in Global Health Status denoted a high quality of life, a high score for Functional Scale meant healthy level of functioning and a high score in Symptom Scale represented high level of problems
Patient's level of psychological distress
Time frame: 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.
The level of psychological distress was measured through the mean scores of the Sinhala version of the Distress Thermometer. The Distress Thermometer is 1 item, an ultra-short, visual analogue screening tool, originally developed in the America for prostate cancer patients in 1998. The Distress Thermometer comes with a Problem List. This has 35 items and it covers 5 life domains (practical, family/social, emotional, spiritual, and physical problems). The Distress Thermometer and Problem List were translated into the Sinhala language (the primary language in Sri Lanka) and cross-culturally adapted to Sri Lanka.
Patient's quality of life related to the Head and Neck condition
Time frame: 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.
This was measured using Head \& Neck-35 module (H\&N-35) by European Organization for Research and Treatment of Cancer. This tool was translated and validated to Sri Lanka through a large-scale multi-centre study. A high score in H\&N-35 module also meant high level of problems whcih meant low quality of life.
1 secondary outcome
Patient's satisfaction
Time frame: This was measured 3 months after the delivery of the intervention package
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 14705607Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.
- Results publication: PubMed 16284994Kadan-Lottick NS, Vanderwerker LC, Block SD, Zhang B, Prigerson HG. Psychiatric disorders and mental health service use in patients with advanced cancer: a report from the coping with cancer study. Cancer. 2005 Dec 15;104(12):2872-81. doi: 10.1002/cncr.21532.
- Results publication: PubMed 1609875Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.
- Results publication: PubMed 19142857Jayasekara H, Rajapaksa LC, Aaronson NK. Health-related quality-of-life in patients with head-and-neck cancer in Sri Lanka: psychometric properties of the 'Sinhala' version of the EORTC QLQ-H&N35. Psychooncology. 2009 Oct;18(10):1116-21. doi: 10.1002/pon.1430.
- Results publication: PubMed 28494483Jayakar R, Choi J, MacKinnon C, Tan S. The cost of major head and neck cancer surgery. N Z Med J. 2017 May 12;130(1455):111-119.
- Results publication: PubMed 18558664Jacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16.
- Results publication: PubMed 17129895Ip WY, Martin CR. Psychometric properties of the 12-item General Health Questionnaire (GHQ-12) in Chinese women during pregnancy and in the postnatal period. Psychol Health Med. 2006 Feb;11(1):60-9. doi: 10.1080/13548500500155750.
- Results publication: PubMed 22984800Infurna FJ, Gerstorf D, Ram N. The nature and correlates of change in depressive symptoms with cancer diagnosis: reaction and adaptation. Psychol Aging. 2013 Jun;28(2):386-401. doi: 10.1037/a0029775. Epub 2012 Sep 17.
- Results publication: PubMed 16331595Hutchison SD, Steginga SK, Dunn J. The tiered model of psychosocial intervention in cancer: a community based approach. Psychooncology. 2006 Jun;15(6):541-6. doi: 10.1002/pon.973.
- Results publication: PubMed 25701663van den Hurk DG, Schellekens MP, Molema J, Speckens AE, van der Drift MA. Mindfulness-Based Stress Reduction for lung cancer patients and their partners: Results of a mixed methods pilot study. Palliat Med. 2015 Jul;29(7):652-60. doi: 10.1177/0269216315572720. Epub 2015 Feb 20.
- Results publication: PubMed 17462312Humphris GM, Ozakinci G. Psychological responses and support needs of patients following head and neck cancer. Int J Surg. 2006;4(1):37-44. doi: 10.1016/j.ijsu.2005.12.004. Epub 2006 Feb 3.
- Results publication: PubMed 472086Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be required at any level for any purpose. Also, keeping to the ethical conduct- I am obliged to protect the confidentiality of the participants. Therefore, as ICP serve no good purpose I will not share them
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irosha Perera, Doctor of Medicine study director
Preventive oral Health Unit, National Dental Hospital, Sri Lanka
Pushpakumara Kandapola Arachchige, Doctor of Medicine study director
National Cancer Institute, Maharagama- Apeksha Hospital, Sri Lanka
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early palliative care integration in people with Oral Cancer and Palliative Supportive Care, run by University of Colombo at 4 sites in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's quality of life (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06726317, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.