Acute Myeloid Leukemia
Conditions
Interventions
None listed
Sponsors
Fukushima Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with relapsed or refractory AML (including progression from other hematological malignancies such as myelodysplastic syndrome or secondary AML) who are 18 years of age or older at the time of informed consent, and who achieved Complete Remission (CR) or CR with incomplete hematologic recovery (CRi) following pharmacotherapy for the first episode of relapsed/refractory AML. 2) Patients who achieved remission within one year prior to consent following treatment for relapsed or refractory AML. 3) Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 or 1 at the time of consent. 4) Patients capable of participating in a web-based interview of approximately one hour.
Exclusion criteria
Exclusion criteria: 1) Patients who relapsed within one year after achieving CR or CRi following initial standard therapy for AML. 2) Patients who relapsed within one year after undergoing hematopoietic stem cell transplantation (HSCT) as part of initial AML treatment. 3) Patients receiving immunosuppressive therapy following HSCT at the time of consent, those with clinically active graft-versus-host disease (GVHD), or those requiring treatment for GVHD (excluding topical steroid use for skin GVHD). 4) Patients who underwent HSCT after pharmacotherapy for relapsed/refractory AML. 5) Patients with comorbid conditions at the time of consent, including congestive heart failure, uncontrolled infections, human immunodeficiency virus (HIV), active hepatitis B or C, or other active liver diseases. 6) Patients who underwent major surgery or received radiation therapy within 28 days prior to the web interview. 7) Patients with a history of participation in clinical trials targeting relapsed/refractory AML. 8) Patients with a prior diagnosis of dementia. 9) Patients currently undergoing treatment for psychiatric disorders. 10) Patients with active concurrent malignancy (excluding those curatively treated with local therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AML-related symptoms and daily-life difficulties, and their perceived impact on everyday living and activities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Experiences related to AML (diagnosis, treatment, etc.) from the time of notification of relapsed/refractory AML up to the present. Coping strategies for burdens and difficulties in daily life, and the kinds of medical support received. | — |
Countries
Japan
Contacts
Public ContactSae Hiroha
Mebix, Inc Clinical Operations
Outcome results
None listed