C26.0 C92.0
Conditions
Interventions
Group 1: Post- Treatment Cancer Patients (CRC and AML)
This is a prospective, interventional, non-pharmacological pilot study designed to evaluate the feasibility of the ONCORELIEF system in real-life
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” - IRST S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with Morphologically confirmed diagnosis of acute myeloid leukemia (AML) (M3 included) in complete remission (CR), complete remission with partial hematologic recovery (CRh) or incomplete hematologic recovery (CRi), which presents one of the following conditions: a. AML receiving demethylating agents +/- venetoclax or maintenance therapy with target therapies b. AML in follow up after treatment and/or allogeneic or autologous stem cell transplantation c. AML receiving chemotherapy as consolidation therapy without indication to autologous or allogeneic stem cell transplantation OR Patients with diagnosis of Colorectal cancer 2. Adult patients = 18 years old 3. Life expectancy > 12 months 4. ECOG PS less or equal to 2 5. Patients in follow up at the clinical site at least every 6 months or less 6. Participant willing and able to give informed consent for participation in the study 7. Patients should have a smartphone and agree to use it for the purposes of the study
Exclusion criteria
Exclusion criteria: The participants may not enter the study if ANY of the following apply: 1. AML Patients in current treatment with indication or in preparation for allogeneic or autologous stem cell transplantation 2. Subjects which present, in the opinion of the Investigator, a reduced cognitive function (such as dementia) or technological illiteracy and are not able to provide reliable information to the study. 3. Other known active malignant neoplastic diseases (patients with medical history of treated neoplastic disease can be included) 4. Patients included in clinical trials may be enrolled in this explorative study, except where otherwise clearly indicated in the experimental protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate feasibility of ONCORELIEF system and use | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To describe patients’ Quality of Life measured by EORTC QLQ C30; 2)To describe patients' well-being | — |
Countries
Germany, Italy
Contacts
Public ContactGabrielle Oestreicher
Universitätsmedizin Mainz
Outcome results
None listed