A study assessing the impact of frailty on therapy in older people with blood cancers

Not Applicable

• Conditions: Frailty; Haematological malignancies; Myelodysplastic syndrome; Acute Myeloid Leukemia; Multiple myeloma; Diffuse Large B cell Lymphoma; Quality of life; Polypharmacy; Cancer - Leukaemia - Acute leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12620000271909
• Lead Sponsor: Dr Angela Molga

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 10 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients must satisfy the following criteria to be enrolled in the study:
·Age 65 years or older
·Diagnosis of haematological malignancy according to relevant classification system
oLymphoma –diffuse B-cell lymphoma (DLBCL)
oMultiple myeloma – for first line treatment or first relapse
oMyelodysplastic syndrome (MDS) and acute myeloid leukemia (AML)
·Ability to provide informed consent. If patients are from a non-english speaking background, informed consent will be determined using an interpreter and including carers
·Able to participate in study assessments
·Life expectancy predicted by the clinician to be over 6 months
·If therapy has commenced at the time of enrollment, then baseline assessments must be completed within 7 days of commencement of therapy

Exclusion Criteria

·Age <65 years of age
·MDS, AML patients previously treated with azacitidine, intensive chemotherapy and/or allogeneic stem cell transplantation
·DLBCL and multiple myeloma patients failed 2 lines of treatment
·End of life care at time of enrollment
·Best supportive care treatment at time of enrollment. Patients can be reconsented if they are then determined for active therapy and meet all other inclusion criteria.
·Enrollment on any other study where non-interventional studies are prohibited
·Any significant condition that would confound the collection or interpretation of data from the study
·Unable or unwilling to provide consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of treatment completion as planned (completing initially planned therapy course) stratified according to each condition and treatment, frailty status and intervention. Treatment completion will be determined according to the number of cycles of therapy completed accessed through medical records, in conjunction with the treating Haematologist's opinion. For example, in Myelodysplastic syndrome at least 4 to 6 cycles of azacitidine need to be completed to determine the response to treatment. If treatment is stopped due to toxicity or lack of response then it is deemed non-completion of therapy. [12 months from the date of enrollment ];Overall survival [12 months from the time of enrollment ]