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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EASE-psy for acute leukemia?

The EASE treatment, which combines psychological and palliative care, was tested in a trial and showed promise in helping patients with acute leukemia manage their emotions and symptoms. Similar psychological interventions have been shown to improve quality of life and immune function in leukemia patients, suggesting potential benefits of EASE-psy. ^{1 2 3 4 5}

How is the EASE-psy treatment different from other treatments for acute leukemia?

The EASE-psy treatment is unique because it combines psychological support with palliative care to help manage emotional and physical symptoms in patients with acute leukemia, focusing on improving their quality of life rather than just treating the disease itself. ^{1 2 3 6 7}

Research Team

Gary Rodin

Principal Investigator

Princess Margaret Hospital, University Health Network

Camilla Zimmerman

Principal Investigator

Princess Margaret Hospital, University Health Network

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

References

1. Germany 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development and validation of the AML-QOL: a quality of life instrument for patients with acute myeloid leukemia. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in acute myeloid leukemia: Where are we now? [2019]

4. Switzerland 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. [2023]

5. England 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. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

Patient ambassador support in newly diagnosed patients with acute leukemia during treatment: a feasibility study. [2021]

7. England 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. [2021]