Myelodysplastic SyndromesNCT04226768
Enhanced Palliative Care in MDS and AML
A study testing Enhanced Haematology Palliative Care ("Fast-track") Group and Conventional Care in people with Myelodysplastic Syndromes, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objectives: The purpose of this study is to evaluate the impact of enhanced haematology palliative care services to the most symptomatic group of blood cancer patients, namely myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Enhanced Haematology Palliative Care ("Fast-track") Group and Conventional Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Jan 2020to 30 Dec 2023
- 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
- Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) defined using the World Health Organization Classification 2016.
- Patients who are able to read and respond to questions in Chinese.
Who cannot join
- Patients who are already receiving care from a palliative care unit will be excluded. Patients who require immediate palliative care service, e.g. end-of-life care, will be excluded and receive palliative care immediately.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine, the University of Hong Kong, Queen Mary Hospital
Hong Kong
About this study
Official title: Impact of Enhanced Haematology Palliative Care Services in Patients With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
Objectives:
The purpose of this study is to evaluate the impact of enhanced haematology palliative care services to the most symptomatic group of blood cancer patients, namely myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).
Read more
Hypothesis to be tested:
To test whether early integration of dedicated palliative care will improve the quality of life, mood and caregiver burden in patients with MDS and AML.
Design and subjects:
This is a 24-month open-label randomized controlled trial. Subjects include patients with MDS and AML.
Study instruments:
Interventions will be carried out by a dedicated team comprising palliative care physicians, haematologists, palliative care nurse specialists, and social workers. Outcome measures will be determined using validated questionnaires and data collection tools.
Interventions:
In this trial, enhanced haematology palliative care integrated to conventional supportive care versus conventional supportive care alone will be compared.
Main outcome measures:
The primary outcome measures include quality of life, mood and caregiver burden. The secondary outcome measures include number of admissions to acute hospital and intensive care and overall survival.
Read the detailed description
Acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) are heterogeneous haematological malignancies associated with guarded long-term outcomes. In AML, 5-year overall survivals is approximately 40% even in young patients. Relapsed or refractory state is seen in up to 40% of patients with AML is associated with a poor outlook especially in patients in-eligible for intensive treatment. MDS is rarely curable except in young patients eligible for allogeneic haematopoietic stem transplantation (HSCT). MDS failing initial treatment have median survivals of less than 6 months. Most patients with AML and MDS are diagnosed after the age of 65, making them physically-ineligible for intensive curative treatment such as HSCT. In addition to inferior survivals, most patients with relapsed or refractory AML and MDS have profound cytopenia resulting in increased risk of infections and need for frequent blood product support. Quality of life (QOL) is affected due to significant symptom burden, treatment side-effects and repeated admission. Furthermore, an increased caregiver burden could be anticipated. Patients with blood cancers, especially those with AML and MDS experience significant physical and psychological symptoms that are comparable to or exceeding that seen in patients with solid organ cancers.
Well-designed randomized controlled trials have clearly demonstrated the benefits of integrating early palliative care concurrently with standard care in cancer patients. Most of these trials demonstrated improved QOL and mood as well as reduction in the utilization of healthcare services. It is now recommended that in-patients and out-patients with advances malignancies should receive dedicated palliative care services early during the course of the disease. Caregivers may also be referred for palliative services to reduce caregiver burden.
Despite the need for specific palliative care services, growing literature suggests that patients with blood cancer are less likely to receive palliative care services early. We have also shown that most patients with AML receive palliative care late and spend most the end-of-life periods in acute hospitals. In addition, there is a lack of studies examining the impact of early dedicated multidisciplinary palliative care services on blood cancer patients' QOL, mood and caregiver burden.
In this study, investigators designed an open-label randomized controlled-study comparing early enhanced palliative care serviced versus usual care in patients with myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Enhanced Haematology Palliative Care ("Fast-track") Group, Conventional Care
- Keywords
- Myelodysplastic syndrome, Acute myeloid leukemia, Palliative care
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Haematology Palliative Care ("Fast-track") GroupOther
Early and proactive multidisciplinary care
Conventional CareOther
Conventional care and referral as indicated
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Haematology Palliative Care ("Fast-track") Group | Experimental | Patients who are assigned to enhanced haematology palliative care ("fast-track" group) will be seen, within 2 days of enrollment, at the out-patient clinic or in-patient setting by the haematology palliative care team that comprises a palliative medicine specialist or a haematologist with palliative care experience, a full-time palliative care nurse, and a medical social worker concentrating on haematology palliative patients. Receives: Other: Enhanced Haematology Palliative Care ("Fast-track") Group |
| Conventional Supportive Care Group | Active comparator | Patients who are assigned to the conventional supportive care group will be under care of haematologists and nurse specialists in haematology After 12 weeks of conventional supportive care, patients randomized to this group will receive services from the palliative care team and assessed every two weeks same the "fast-track" group Receives: Other: Conventional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Quality of Life (MQOL) Questionnaire Score
It is a 17-item patient-rated measure of QOL for patients receiving palliative care.This questionnaire was translated and validated in Hong Kong. The questionnaire consists of five domains: physical well-being (five items), psychological well-being (six items), existential well-being (four items), support (two items), and sexual function (one item). In addition, there is a single item to rate their perceived quality of life. The response categories are based on a numerical scale from 0-10 with verbal anchors at the end of the scale. For the final statistical analysis, all scores are transposed on a 0-10 scale, with 0 representing the least and 10 indicating the most desirable situation. The mean total QOL score is the average of all the 5 domain scores, with 0 representing the worst situation. The overall validation results of the MQOL-HK were acceptable. Cronbach's α for the MQOL-HK subscale ranged from 0.68 to 0.85.
Measured: 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Levels of anxiety and depression were self-rated by HADS, which has been found to perform well as a test for such symptoms in the general population, in cancer patients and in primary care patients. Subjects decide on how each item applies to them on a scale ranging from no feelings of anxiety or depression (0) to severe feelings of anxiety or depression (3), with scores ranging from 0 to 21 on each subscale. A subscale score of 8 to 10 indicates a possible case of anxiety or depression, whereas a subscale score of 11 or higher indicates a definite case of anxiety or depression. Severe depression or anxiety disorders are suspected for subjects scoring 15 or higher.24 The Cantonese-Chinese version of the HADS25 has been found to have good internal consistency (Cronbach's α=0.77), reasonable sensitivity (0.79) and specificity (0.80), as well as positive (0.77) and negative predictive values (0.82).
Measured: 24 weeks
Zariet Burden Interview (ZBI)
The ZBI is a widely used 22-item assessment tool for measuring the caregiver's perceived burden in providing family care. The questionnaire was translated, and modified according to Hong Kong cultural standards.
The ZBI scale was developed to measure burden among family caregivers of persons with dementia; however, it has been used in other populations and was selected for this study because of the high reliability and validity of the Chinese version, indicated by a Cronbach's alpha of 0.99 and a correlation coefficient of 0.81. The correlation between ZBI and general Health Questionnaire was 0.59 (p<0.001), and the correlation between Caregiver Activity Survey was 0.057 (p<0.001), suggesting high conceptual validity.
The items were scored on a five-point scale ranging from 0 (never) to 4 (always). Scores were calculated by summing up the total chosen statement which ranges from 0 to 88, that higher scores implying greater perceived caregiver burden.
Measured: 24 weeks
Secondary outcomes (3)
Number of admissions to acute hospital
Number
Measured: 24 weeks
Number of admission to intensive care unit
Number
Measured: 24 weeks
Overall survival
Time (in weeks) from the data of recruitment to death or latest follow-up
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start9 Jan 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gill Harinder Singh, Harry, The University of Hong Kong
- Investigators
- Harinder Singh Harry Gill, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226768
- Sponsor's protocol ID
- PC001
- Status last verified
- Oct 2022
- First submitted
- 6 Jan 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood. 2015 Jul 16;126(3):319-27. doi: 10.1182/blood-2014-10-551911. Epub 2015 Apr 7.
PubMed 25852056Juliusson G, Antunovic P, Derolf A, Lehmann S, Mollgard L, Stockelberg D, Tidefelt U, Wahlin A, Hoglund M. Age and acute myeloid leukemia: real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood. 2009 Apr 30;113(18):4179-87. doi: 10.1182/blood-2008-07-172007. Epub 2008 Nov 13.
PubMed 19008455Prebet T, Gore SD, Esterni B, Gardin C, Itzykson R, Thepot S, Dreyfus F, Rauzy OB, Recher C, Ades L, Quesnel B, Beach CL, Fenaux P, Vey N. Outcome of high-risk myelodysplastic syndrome after azacitidine treatment failure. J Clin Oncol. 2011 Aug 20;29(24):3322-7. doi: 10.1200/JCO.2011.35.8135. Epub 2011 Jul 25.
PubMed 21788559Epstein AS, Goldberg GR, Meier DE. Palliative care and hematologic oncology: the promise of collaboration. Blood Rev. 2012 Nov;26(6):233-9. doi: 10.1016/j.blre.2012.07.001. Epub 2012 Aug 5.
PubMed 22874874Manitta V, Zordan R, Cole-Sinclair M, Nandurkar H, Philip J. The symptom burden of patients with hematological malignancy: a cross-sectional observational study. J Pain Symptom Manage. 2011 Sep;42(3):432-42. doi: 10.1016/j.jpainsymman.2010.12.008. Epub 2011 Apr 7.
PubMed 21477979Fadul NA, El Osta B, Dalal S, Poulter VA, Bruera E. Comparison of symptom burden among patients referred to palliative care with hematologic malignancies versus those with solid tumors. J Palliat Med. 2008 Apr;11(3):422-7. doi: 10.1089/jpm.2007.0184.
PubMed 18363482Manitta VJ, Philip JA, Cole-Sinclair MF. Palliative care and the hemato-oncological patient: can we live together? A review of the literature. J Palliat Med. 2010 Aug;13(8):1021-5. doi: 10.1089/jpm.2009.0267.
PubMed 20712465Ferrell BR, Temel JS, Temin S, Alesi ER, Balboni TA, Basch EM, Firn JI, Paice JA, Peppercorn JM, Phillips T, Stovall EL, Zimmermann C, Smith TJ. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Jan;35(1):96-112. doi: 10.1200/JCO.2016.70.1474. Epub 2016 Oct 28.
PubMed 28034065Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
PubMed 19690306Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.
PubMed 25800768Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, Li Z, Frost J, Dragnev KH, Akyar I, Hegel MT, Bakitas MA. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1446-52. doi: 10.1200/JCO.2014.58.7824. Epub 2015 Mar 23.
PubMed 25800762Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
PubMed 24559581LeBlanc TW, El-Jawahri A. When and why should patients with hematologic malignancies see a palliative care specialist? Hematology Am Soc Hematol Educ Program. 2015;2015:471-8. doi: 10.1182/asheducation-2015.1.471.
PubMed 26637760Cheng HW, Li CW, Chan KY, Au HY, Chan PF, Sin YC, Szeto Y, Sham MK. End-of-life characteristics and palliative care provision for elderly patients suffering from acute myeloid leukemia. Support Care Cancer. 2015 Jan;23(1):111-6. doi: 10.1007/s00520-014-2333-x. Epub 2014 Jul 5.
PubMed 24996833Cheng HW. Optimizing End-of-Life Care for Patients With Hematological Malignancy: Rethinking the Role of Palliative Care Collaboration. J Pain Symptom Manage. 2015 May;49(5):e5-6. doi: 10.1016/j.jpainsymman.2015.01.008. Epub 2015 Feb 2. No abstract available.
PubMed 25656326
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Enhanced Haematology Palliative Care Services in Patients With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
- ClinicalTrials.gov ID
- NCT04226768
- Acronym / sponsor ID
- PC001
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Myelodysplastic syndrome, Acute myeloid leukemia, Palliative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Jan 2020 (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.
Objectives:
The purpose of this study is to evaluate the impact of enhanced haematology palliative care services to the most symptomatic group of blood cancer patients, namely myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).
Hypothesis to be tested:
To test whether early integration of dedicated palliative care will improve the quality of life, mood and caregiver burden in patients with MDS and AML.
Design and subjects:
This is a 24-month open-label randomized controlled trial. Subjects include patients with MDS and AML.
Study instruments:
Interventions will be carried out by a dedicated team comprising palliative care physicians, haematologists, palliative care nurse specialists, and social workers. Outcome measures will be determined using validated questionnaires and data collection tools.
Interventions:
In this trial, enhanced haematology palliative care integrated to conventional supportive care versus conventional supportive care alone will be compared.
Main outcome measures:
The primary outcome measures include quality of life, mood and caregiver burden. The secondary outcome measures include number of admissions to acute hospital and intensive care and overall survival.
Detailed description
Acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) are heterogeneous haematological malignancies associated with guarded long-term outcomes. In AML, 5-year overall survivals is approximately 40% even in young patients. Relapsed or refractory state is seen in up to 40% of patients with AML is associated with a poor outlook especially in patients in-eligible for intensive treatment. MDS is rarely curable except in young patients eligible for allogeneic haematopoietic stem transplantation (HSCT). MDS failing initial treatment have median survivals of less than 6 months. Most patients with AML and MDS are diagnosed after the age of 65, making them physically-ineligible for intensive curative treatment such as HSCT. In addition to inferior survivals, most patients with relapsed or refractory AML and MDS have profound cytopenia resulting in increased risk of infections and need for frequent blood product support. Quality of life (QOL) is affected due to significant symptom burden, treatment side-effects and repeated admission. Furthermore, an increased caregiver burden could be anticipated. Patients with blood cancers, especially those with AML and MDS experience significant physical and psychological symptoms that are comparable to or exceeding that seen in patients with solid organ cancers.
Well-designed randomized controlled trials have clearly demonstrated the benefits of integrating early palliative care concurrently with standard care in cancer patients. Most of these trials demonstrated improved QOL and mood as well as reduction in the utilization of healthcare services. It is now recommended that in-patients and out-patients with advances malignancies should receive dedicated palliative care services early during the course of the disease. Caregivers may also be referred for palliative services to reduce caregiver burden.
Despite the need for specific palliative care services, growing literature suggests that patients with blood cancer are less likely to receive palliative care services early. We have also shown that most patients with AML receive palliative care late and spend most the end-of-life periods in acute hospitals. In addition, there is a lack of studies examining the impact of early dedicated multidisciplinary palliative care services on blood cancer patients' QOL, mood and caregiver burden.
In this study, investigators designed an open-label randomized controlled-study comparing early enhanced palliative care serviced versus usual care in patients with myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Haematology Palliative Care ("Fast-track") Group | Experimental | Other: Enhanced Haematology Palliative Care ("Fast-track") GroupPatients who are assigned to enhanced haematology palliative care ("fast-track" group) will be seen, within 2 days of enrollment, at the out-patient clinic or in-patient setting by the haematology palliative care team that comprises a palliative medicine specialist or a haematologist with palliative care experience, a full-time palliative care nurse, and a medical social worker concentrating on haematology palliative patients. |
| Conventional Supportive Care Group | Active comparator | Other: Conventional CarePatients who are assigned to the conventional supportive care group will be under care of haematologists and nurse specialists in haematology After 12 weeks of conventional supportive care, patients randomized to this group will receive services from the palliative care team and assessed every two weeks same the "fast-track" group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) defined using the World Health Organization Classification 2016.
- Patients who are able to read and respond to questions in Chinese.
Key exclusion criteria (1 listed)
- Patients who are already receiving care from a palliative care unit will be excluded. Patients who require immediate palliative care service, e.g. end-of-life care, will be excluded and receive palliative care immediately.
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 |
|---|---|---|
| Enhanced Haematology Palliative Care ("Fast-track") GroupEarly and proactive multidisciplinary care | Other | Enhanced Haematology Palliative Care ("Fast-track") Group |
| Conventional CareConventional care and referral as indicated | Other | Conventional Supportive Care Group |
Primary outcome
McGill Quality of Life (MQOL) Questionnaire Score
Time frame: 24 weeks
It is a 17-item patient-rated measure of QOL for patients receiving palliative care.This questionnaire was translated and validated in Hong Kong. The questionnaire consists of five domains: physical well-being (five items), psychological well-being (six items), existential well-being (four items), support (two items), and sexual function (one item). In addition, there is a single item to rate their perceived quality of life. The response categories are based on a numerical scale from 0-10 with verbal anchors at the end of the scale. For the final statistical analysis, all scores are transposed on a 0-10 scale, with 0 representing the least and 10 indicating the most desirable situation. The mean total QOL score is the average of all the 5 domain scores, with 0 representing the worst situation. The overall validation results of the MQOL-HK were acceptable. Cronbach's α for the MQOL-HK subscale ranged from 0.68 to 0.85.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 24 weeks
Levels of anxiety and depression were self-rated by HADS, which has been found to perform well as a test for such symptoms in the general population, in cancer patients and in primary care patients. Subjects decide on how each item applies to them on a scale ranging from no feelings of anxiety or depression (0) to severe feelings of anxiety or depression (3), with scores ranging from 0 to 21 on each subscale. A subscale score of 8 to 10 indicates a possible case of anxiety or depression, whereas a subscale score of 11 or higher indicates a definite case of anxiety or depression. Severe depression or anxiety disorders are suspected for subjects scoring 15 or higher.24 The Cantonese-Chinese version of the HADS25 has been found to have good internal consistency (Cronbach's α=0.77), reasonable sensitivity (0.79) and specificity (0.80), as well as positive (0.77) and negative predictive values (0.82).
Zariet Burden Interview (ZBI)
Time frame: 24 weeks
The ZBI is a widely used 22-item assessment tool for measuring the caregiver's perceived burden in providing family care. The questionnaire was translated, and modified according to Hong Kong cultural standards. The ZBI scale was developed to measure burden among family caregivers of persons with dementia; however, it has been used in other populations and was selected for this study because of the high reliability and validity of the Chinese version, indicated by a Cronbach's alpha of 0.99 and a correlation coefficient of 0.81. The correlation between ZBI and general Health Questionnaire was 0.59 (p<0.001), and the correlation between Caregiver Activity Survey was 0.057 (p<0.001), suggesting high conceptual validity. The items were scored on a five-point scale ranging from 0 (never) to 4 (always). Scores were calculated by summing up the total chosen statement which ranges from 0 to 88, that higher scores implying greater perceived caregiver burden.
3 secondary outcomes
Number of admissions to acute hospital
Time frame: 24 weeks
Number of admission to intensive care unit
Time frame: 24 weeks
Overall survival
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Results publication: PubMed 25852056Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood. 2015 Jul 16;126(3):319-27. doi: 10.1182/blood-2014-10-551911. Epub 2015 Apr 7.
- Results publication: PubMed 19008455Juliusson G, Antunovic P, Derolf A, Lehmann S, Mollgard L, Stockelberg D, Tidefelt U, Wahlin A, Hoglund M. Age and acute myeloid leukemia: real world data on decision to treat and outcomes from the Swedish Acute Leukemia Registry. Blood. 2009 Apr 30;113(18):4179-87. doi: 10.1182/blood-2008-07-172007. Epub 2008 Nov 13.
- Results publication: PubMed 21788559Prebet T, Gore SD, Esterni B, Gardin C, Itzykson R, Thepot S, Dreyfus F, Rauzy OB, Recher C, Ades L, Quesnel B, Beach CL, Fenaux P, Vey N. Outcome of high-risk myelodysplastic syndrome after azacitidine treatment failure. J Clin Oncol. 2011 Aug 20;29(24):3322-7. doi: 10.1200/JCO.2011.35.8135. Epub 2011 Jul 25.
- Results publication: PubMed 22874874Epstein AS, Goldberg GR, Meier DE. Palliative care and hematologic oncology: the promise of collaboration. Blood Rev. 2012 Nov;26(6):233-9. doi: 10.1016/j.blre.2012.07.001. Epub 2012 Aug 5.
- Results publication: PubMed 21477979Manitta V, Zordan R, Cole-Sinclair M, Nandurkar H, Philip J. The symptom burden of patients with hematological malignancy: a cross-sectional observational study. J Pain Symptom Manage. 2011 Sep;42(3):432-42. doi: 10.1016/j.jpainsymman.2010.12.008. Epub 2011 Apr 7.
- Results publication: PubMed 18363482Fadul NA, El Osta B, Dalal S, Poulter VA, Bruera E. Comparison of symptom burden among patients referred to palliative care with hematologic malignancies versus those with solid tumors. J Palliat Med. 2008 Apr;11(3):422-7. doi: 10.1089/jpm.2007.0184.
- Results publication: PubMed 20712465Manitta VJ, Philip JA, Cole-Sinclair MF. Palliative care and the hemato-oncological patient: can we live together? A review of the literature. J Palliat Med. 2010 Aug;13(8):1021-5. doi: 10.1089/jpm.2009.0267.
- Results publication: PubMed 28034065Ferrell BR, Temel JS, Temin S, Alesi ER, Balboni TA, Basch EM, Firn JI, Paice JA, Peppercorn JM, Phillips T, Stovall EL, Zimmermann C, Smith TJ. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Jan;35(1):96-112. doi: 10.1200/JCO.2016.70.1474. Epub 2016 Oct 28.
- Results publication: PubMed 19690306Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
- Results publication: PubMed 25800768Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, Dionne-Odom JN, Frost J, Dragnev KH, Hegel MT, Azuero A, Ahles TA. Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.
- Results publication: PubMed 25800762Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, Li Z, Frost J, Dragnev KH, Akyar I, Hegel MT, Bakitas MA. Benefits of Early Versus Delayed Palliative Care to Informal Family Caregivers of Patients With Advanced Cancer: Outcomes From the ENABLE III Randomized Controlled Trial. J Clin Oncol. 2015 May 1;33(13):1446-52. doi: 10.1200/JCO.2014.58.7824. Epub 2015 Mar 23.
- Results publication: PubMed 24559581Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
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.
Harinder Singh Harry Gill, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Haematology Palliative Care ("Fast-track") Group and Conventional Care in people with Myelodysplastic Syndromes, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Results are not available in the source record.
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?
McGill Quality of Life (MQOL) Questionnaire Score (time frame: 24 weeks). 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 NCT04226768, which also lists 25 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 4 Oct 2022.