Enhanced Palliative Care in MDS and AML

NCT04226768 | Unknown DMC

• 1 other identifier: PC001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic syndrome; Acute myeloid leukemia; Palliative care

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  24 weeks

Secondary Outcomes (3)

• Number of admissions to acute hospital

  24 weeks

• Number of admission to intensive care unit

  24 weeks

• Overall survival

  24 weeks

Study Arms (2)

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.

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

Other: Conventional Care

Interventions

Enhanced Haematology Palliative Care ("Fast-track") Group OTHER

Early and proactive multidisciplinary care

Enhanced Haematology Palliative Care ("Fast-track") Group

Conventional Care OTHER

Conventional care and referral as indicated

Conventional Supportive Care Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Medicine, the University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Harinder Singh Harry Gill, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: January 9, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)