Emotion and Symptom-Focused Engagement (EASE) for Acute Leukemia

(EASE Trial)

Recruiting at 4 trial locations

Overseen By Harriet Richardson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Disqualifiers: Communication difficulties, On-site counseling, On-site palliative, Acute promyelocytic leukemia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

266 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new support program, EASE-psy, can assist individuals recently diagnosed with acute leukemia. The program combines emotional support with symptom checks to determine if it reduces stress and physical symptoms more effectively than usual care. Participants will receive either the usual care for leukemia or the usual care plus this new program. This trial may suit individuals newly diagnosed with specific types of acute leukemia who are about to begin curative treatment. As an unphased trial, it offers a unique opportunity to contribute to innovative support strategies that could improve care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EASE intervention is safe?

Research shows that the Emotion and Symptom-Focused Engagement (EASE) treatment is generally easy for participants to handle. In past studies, most people completed the sessions without major issues. For example, one study found that over 86% of participants finished more than half of the EASE-psy sessions, suggesting that people can manage the treatment without significant problems.

The EASE approach combines emotional support with regular symptom checks and offers referrals for extra care if needed, focusing on both the physical symptoms and the emotional well-being of participants. While specific side effects aren't detailed, the high completion rates suggest that serious side effects are rare or manageable.

Overall, EASE appears to be a safe option, with no major safety concerns reported in the available data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EASE-psy treatment for acute leukemia because it focuses on both emotional and physical support, which is different from standard treatments that primarily target the disease itself with chemotherapy and radiation. EASE-psy uniquely combines psychological support with physical care, aiming to improve the overall well-being of patients. This holistic approach could enhance quality of life and potentially improve treatment outcomes by addressing emotional health alongside physical symptoms.

What evidence suggests that the EASE intervention is effective for reducing psychological distress and physical symptom burden in acute leukemia?

Research has shown that the EASE program might help people with acute leukemia by reducing stress and physical symptoms. In this trial, participants will receive either usual care or usual care plus the EASE Intervention, which includes EASE-psy and EASE-phys components. One study found that patients experienced less stress and felt better overall. Another study found that EASE was practical for newly diagnosed patients and suggested it could effectively reduce stress. The program offers emotional support, checks on symptoms, and makes timely referrals for extra care, which appears promising for managing both mental and physical symptoms. Overall, these early findings suggest EASE could be a useful addition to regular care for improving patient outcomes. ^{1 4 5 6 7}

Who Is on the Research Team?

Gary Rodin

Principal Investigator

Princess Margaret Hospital, University Health Network

Camilla Zimmerman

Principal Investigator

Princess Margaret Hospital, University Health Network

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've been newly diagnosed with acute leukemia (AML or ALL) and are within two weeks of hospital admission. They must pass a cognitive test, plan to receive induction chemotherapy, speak English fluently, and be able to complete questionnaires. Excluded are those already receiving palliative care or psychological counseling in the hospital, diagnosed with certain types of leukemia, or have major communication issues.

Inclusion Criteria

I was recently diagnosed with acute leukemia and admitted to the hospital within the last 2 weeks.

I can pass a basic memory and concentration test or have an exception due to special circumstances.

I am currently undergoing or about to start chemotherapy aimed at curing my cancer.

Exclusion Criteria

I am currently getting palliative care in a hospital.

I have been diagnosed with a specific type of leukemia.

I am currently getting psychological or psychiatric help in a hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive induction chemotherapy and supportive psychotherapy (EASE-psy) during the initial weeks of treatment

4 weeks

Inpatient treatment

Symptom Screening and Palliative Care

Symptom screening with triggered referral to early palliative care (EASE-phys) for symptom control

4 weeks

Follow-up

Participants are monitored for psychological distress and physical symptom burden

52 weeks

Assessments at 4, 8, 12, 26, and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EASE-psy

Trial Overview The study tests if a new intervention called EASE—combining psychological support with symptom screening and early palliative care referrals—can reduce distress and symptoms in acute leukemia patients compared to usual care alone. Participants will be randomly divided into two groups: one receives standard treatment; the other gets standard plus EASE.

How Is the Trial Designed?

Group I: Other: Usual Care Experimental Treatment 1 Intervention

Group II: Behavioral: Usual Care + EASE Intervention-psy Experimental Treatment 1 Intervention

EASE Intervention = EASE-psy + EASE-phys

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Princess Margaret Hospital, University Health Network

Collaborator

Trials

1

Recruited

270+

Published Research Related to This Trial

The study involving 36 newly diagnosed acute leukemia patients and 25 trained patient ambassadors demonstrated that patient ambassador support is both feasible and safe, leading to high satisfaction among participants.

Patients receiving support showed improvements in psychosocial outcomes, suggesting that this model could enhance existing care services in hematology by fostering active partnerships between current and former patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient ambassador support in newly diagnosed patients with acute leukemia during treatment: a feasibility study. Nørskov, KH., Overgaard, D., Boesen, J., et al.[2021]

In a non-randomized trial involving 28 children with acute lymphoblastic leukemia, a psychoneuroimmunology-based intervention significantly improved immune markers and quality of life compared to a control group receiving health psychoeducation.

The intervention not only enhanced immune responses but also reduced the duration of fever and the need for medications like antipyretics and antibiotics, suggesting potential benefits in reducing hospital costs and improving patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological intervention based on psychoneuroimmunology improves clinical evolution, quality of life, and immunity of children with leukemia: A preliminary study. Chacin-Fernández, J., Chacin Fuenmayor, M., Piñerua-Shuhaibar, L., et al.[2020]

In a study of 655 cancer patients starting chemotherapy, emotional symptoms like anxiety and depression improved over time, but were still linked to higher levels of problem-related distress throughout treatment.

Patients with greater initial problem-related distress experienced more severe emotional symptoms, indicating a need for ongoing psychosocial support during cancer treatment to help manage these emotional challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between hospital anxiety and depression scale and problem-related distress in patients with cancer in a Brazilian private institution. Bergerot, CD., Razavi, M., Philip, EJ., et al.[2021]

A systematic review of 41 studies on acute myeloid leukemia and high-risk myelodysplastic syndrome highlighted the importance of incorporating patient-reported outcome (PRO) measures to assess quality of life alongside treatment efficacy.

Despite challenges like high dropout rates and varying measurement tools, effective use of PROs can offer valuable insights into patient experiences and inform better clinical care and future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in acute myeloid leukemia: Where are we now? Buckley, SA., Kirtane, K., Walter, RB., et al.[2019]

The AML-QOL is a newly developed and validated quality of life instrument specifically for patients with acute myeloid leukemia (AML), based on feedback from 16 patients and 8 medical providers, and validated with 202 patients undergoing treatment.

The instrument shows high reliability and validity, with a median internal consistency of 0.85 and good sensitivity to changes in quality of life, making it a useful tool for assessing the impact of AML and its treatment on patients' lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the AML-QOL: a quality of life instrument for patients with acute myeloid leukemia. Buckley, SA., Halpern, AB., Othus, M., et al.[2021]

A study involving 180 patients with acute leukemia found that psychological interventions, particularly a combination of cognitive intervention and progressive muscle relaxation (PMR), significantly improved quality of life (QoL) compared to usual care.

Despite the improvements in QoL, the study did not find significant differences in remission rates among the different intervention groups, suggesting that while psychological support is beneficial for well-being, it may not directly impact cancer remission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of different psychological interventions on quality of life and remission rate in patients with acute leukemia receiving chemotherapy: A randomized controlled trial. Peng, F., Li, H., Zhang, J., et al.[2023]

The Emotion And Symptom-focused Engagement (EASE) intervention, which combines tailored psychotherapy and physical symptom screening, was found to be feasible for patients with acute leukemia, with 76% of participants retained over 12 weeks and high completion rates of therapy sessions.

EASE demonstrated significant improvements in traumatic stress symptoms and pain management compared to usual care, suggesting it may be an effective addition to standard treatment for acute leukemia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia. Rodin, G., Malfitano, C., Rydall, A., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41161769/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0nK-FGmcPzruPpJferMpyd8mRld7hsB1ra05TRUDXN6&fc=None&ff=20251030030852&v=2.18.0.post22+67771e2

The Emotion and Symptom-Focused Engagement (EASE) ... Randomized controlled trials are warranted to evaluate its efficacy in reducing traumatic stress and improving caregiver well-being. Trial ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04224974

Emotion and Symptom-Focused Engagement Trial for ... A phase II trial of EASE in patients with newly diagnosed acute leukemia demonstrated feasibility and preliminary evidence that it reduces psychological ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123080977

Canadian Cancer Trials Group SC.26 - Emotion and ... EASE is a novel manualized intervention that combines psychological support with routine symptom screening plus triggered referral to palliative care for ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31001692/

Emotion And Symptom-focused Engagement (EASE) EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2017.35.15_suppl.7041

Emotion and Symptom-focused Engagement (EASE) Predefined feasibility outcomes were all met: > 86% (19/22) of EASE participants (goal > 64%) completed > 50% of proposed EASE-psy sessions; 64% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02353559

Emotion And Symptom-focused Engagement (EASE): An ... The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused ...

7. clinicaltrial.be clinicaltrial.be/en/details/58905?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Emotion and Symptom-Focused Engagement Trial for ... A phase II trial of EASE in patients with newly diagnosed acute leukemia demonstrated feasibility and preliminary evidence that it reduces ...