A program to support emotional and physical health in patients with acute leukemia
Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia
This study tests if a new support program that includes therapy and symptom checks can help people newly diagnosed with acute leukemia feel better emotionally and physically compared to standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Canadian Cancer Trials Group Research network |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Hamilton, Ontario and 4 other locations) |
| Trial ID | NCT04224974 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a novel intervention called Emotion and Symptom-focused Engagement (EASE) for individuals newly diagnosed with acute leukemia. Participants will be divided into two groups: one receiving standard care and the other receiving standard care plus the EASE intervention, which includes tailored psychotherapy and symptom screening with referrals to palliative care. The aim is to reduce psychological distress and physical symptom burden during the initial treatment phase. The study builds on preliminary findings suggesting that EASE may improve patient outcomes compared to usual care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with acute leukemia and are about to begin induction therapy.
Not a fit: Patients who are not fluent in English or those who do not meet the cognitive screening criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the emotional and physical well-being of patients newly diagnosed with acute leukemia.
How similar studies have performed: Previous studies have shown preliminary success with similar psychosocial interventions in cancer care, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hamilton, Ontario and 4 other locations
- Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
- Odette Cancer Centre — Toronto, Ontario, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Harriet Richardson
- Email: hrichardson@ctg.queensu.ca
- Phone: 613-533-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.