NCT04224974 Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia
| NCT ID | NCT04224974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Canadian Cancer Trials Group |
| Condition | Acute Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 266 participants |
| Start Date | 2022-01-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 266 participants in total. It began in 2022-01-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to find out whether a novel manualized intervention, called Emotion and Symptom-focused Engagement (EASE), that combines psychological support with symptom screening plus triggered referral to early palliative care for symptom control, reduces psychological distress and physical symptom burden in individuals newly diagnosed with acute leukemia. To do this, half of the participants in this study will receive the usual care offered to patients with acute leukemia and half of the participants will receive usual care plus the EASE intervention.
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed AL (acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) chronic myelogenous leukemia (CML) in blast crisis; T-cell leukemia lymphoma (TLL), and AL of ambiguous lineage) and is recruited up to 1 week prior to hospital admission or within 2 weeks of hospital admission. For patients diagnosed with a mixed phenotype AL, the dominant sub-type must be identified for stratification purposes. * Receiving or expected to receive induction therapy with curative intent at the time of recruitment. * Age ≥ 18 years. * Ability to pass the cognitive screening test at the time of recruitment (Short Orientation-Memory-Concentration Test (SOMC) score ≥ 20), unless deemed suitable at the CRA's discretion (e.g. in extenuating circumstances such as interruptions during the administration of the measure or when patients report a learning disability that can influence the results). * Patient is fluent in English and is able (i.e. sufficiently literate and competent) and willing to complete the baseline questionnaires in English. Ability but unwillingness to complete the baseline questionnaires will make the patient ineligible. Exclusion Criteria: * Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or inability to speak). * Receiving on-site (in hospital) psychological/psychiatric counseling at the time of recruitment. * Receiving on-site (in hospital) palliative care services at the time of recruitment. * A diagnosis of acute promyelocytic leukemia.
Contact & Investigator
Gary Rodin
STUDY CHAIR
Princess Margaret Hospital, Canada
Frequently Asked Questions
Who can join the NCT04224974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04224974 currently recruiting?
Yes, NCT04224974 is actively recruiting participants. Contact the research team at hrichardson@ctg.queensu.ca for enrollment information.
Where is the NCT04224974 trial being conducted?
This trial is being conducted at Hamilton, Canada, Kingston, Canada, Ottawa, Canada, Toronto, Canada and 1 additional location.
Who is sponsoring the NCT04224974 clinical trial?
NCT04224974 is sponsored by Canadian Cancer Trials Group. The principal investigator is Gary Rodin at Princess Margaret Hospital, Canada. The trial plans to enroll 266 participants.
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