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

All patients enrolled in the trial will undergo a panel of screening tools performed by a trained study member. The screening tools will be conducted face to face in the clinic setting where required and over the phone where that assessment allows. The following tools have been selected to evaluate each domain of ageing, as well as addressing important 'geriatric syndromes'. The scores reflecting impairment are listed and were selected based on either standardised cut-offs or most frequently reported cut-offs used in the literature: 1. Functional status: -Activities of Daily Living (ADL) tool – basic functions including bathing, dressing, toileting, continence, transfers and feeding. A total score less than or equal to 5 out of 6 indicates the presence of impairment. -Instrumental Activities of Daily Living (iADL) tool – higher functional activities including using a phone, shopping, food preparation, housekeeping, laundry, transport, medication and financial management. Scores indicative of the presence of impairments are less than or equal to 7 out of 8 for women and less than or equal to 4 out of 5 for men 2. Cognition: -Standardised minimental state examination: score less than or equal to 24/30 indicates significant impairment. Additionally a short term recall score of less than or equal to 2/3 will be flagged as abnormal as mild cognitive deficits can progress to more severe impairment. This is will be an important longitudinal analysis with repeated testing. -Frontal Assessment Battery: less than or equal to 12/18 The Rowland Universal Dementia Assessment Score (RUDAS) will be used for culturally and linguistically diverse persons: less than or equal to 22/30 2. Comorbidity: -Charlson Comorbidity Index (CCI) is reflective of the burden of comorbidity which is correlated with mortality and progression free survival in the oncological setting A score of more than or equal to 3 indicates a significantly high burden. -Other significant comorbidities specific to this population not captured by the CCI will also be recorded and if present will be recorded as abnormal. 3. Mental health: -Short version Geriatric Depression Scale GDS-15: A score of more than or equal to 5 out of 15 indicates the need to evaluate the patient’s mental health for possible depression -Hospital Anxiety and Depression Scale: HAD-S >8 4. Nutrition: Mini Nutritional Assessment (MNA): A score of 17 to 23.5 indicates a risk of malnutrition and a score <17 indicates malnourishment. The threshold for an abnormal score will therefore be 23.5. 5. Mobility and frailty: -Timed Up and Go (TUG) test which assesses dynamic mobility and balance for mobile patients: A cut off time of 13.5 seconds or more indicates a higher risk of falls and frailty -Grip strength using a handheld dynamometer 6. Patient reported outcome measures: EORTC QLQ-C30 QOL Questionnaire. Each domain will be evaluated. Score changes of more than or equal to 10 points will be highlighted for clinical attention as these represent changes in supportive care needs. 7. The Geriatric Risk G8 screening tool The baseline panel will be performed prior to the commencement of therapy or within 7 days of commencement of their cycle of therapy to minimize the confounding effect of therapy on the results of the tools. The screening tools are repeated at 2 to 3 monthly intervals to 12 months from enrollment in the study. The entire assessment panel from our previous experience takes 30-45 minutes. Patients with abnormal scores on at least 2 screening tools at baseline will be enrolled in the randomized arm - Stream 2. In stream 2 patients will be randomized within each condition - with Diffuse Large B Cell Lymphoma (DLBCL) and Multiple Myeloma (MM), Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in a 1:1 fashion to either control Arm A or intervention Arm B. Arm A: Standard of care: patients will be managed by their Haematologist in line with current protocols and procedures. There is a Nursing case coordinator at our institution for each disease stream as part of standard of care however there is no Oncogeriatric service or support. Screening assessments will be repeated during therapy as above. After the completion or cessation of therapy patients are usually followed up at 3 monthly intervals in the Haematology outpatient department as part of standard of care. Repeat assessments will occur at these standard follow-up appointments. Cross over to arm B is not permitted. Arm B: Randomisation within each disease stream will occur to one of 2 management pathways: • Standard of care (SOC): Patients are managed in line with current protocols/procedures • Coordinated Multidisciplinary Case Management (CM2): This is based on the Comprehensive Geriatric Assessment model and consists of discussion at Multidisciplinary Meeting (physicians, nursing, pharmacy, allied health) where interventions will be tailored for the patient. Cases may be discussed more than once depending on their complexity and changing needs of the patient. The Multidiscplinary meeting will be scheduled for 90 minutes to discuss and document interventions. •The patient will be reviewed by a Geriatrician or General Physician with expertise in Geriatric Medicine, to provide a sustainable model to services that do not have access to a Geriatrician. The initial consult will be face to face, lasting approximately an hour for a comprehensive review. Follow-up appointments will be determined by the clinician and in line with patient preference. Telemedicine options can also be offered to patients if appropriate. Interventions according to deficits have been predetermined to reduce variation in clinical practice between clinicians. Interventions will be recommended in joint decision making with the patient +/- carer. If any interventions are declined this will be recorded. Additional interventions can be recommended by the physician as required and will be recorded. Interventions recommended will be followed up with monthly phone calls. Examples of interventions according to domains: - Chronic disease management, if CCI is more than or equal to 3: Optimisation of conditions, reconciliation with clinical practice guidelines including lifestyle modifications for example reduced salt diets and fluid restriction for heart failure, diabetic diets for diabetics. Referral for further investigation/evaluation where appropriate and necessary. - Functional status: Refer for appropriate physical therapy program or allied health assessment (physiotherapy or exercise physiologist). Referral to support providers +/- My aged care (may need occupational therapy assessment) - Cognitive status: Stratified according to presence of cognitive impairment. Further memory evaluation, management as indicated, carer referral to community support services including support groups for counselling and education, during hospitalisation ensuring that the ward is adherent to Delirium Clinical Care Standards and Dementia Care in Hospitals Program - Nutritional status: Dietitian referral, dietary counselling, nutritional supplements. Speech pathology assessment or dental review may be indicated for denture fitting or dental hygiene if not already done as part of standard of care. - Mental Health: GDS-15 >5, HAD-S >8. Further evaluation/referral either with the primary care provider (GP management plan) or specialist services if severe - Medication reconciliation: correspondence with primary care provider and haematologist. - Patient reported outcome measures, EORTC QLQ-C30 QOL Questionnaire – significant changes in domains or change in score of more than or equal to 10 points will prompt a review of patient’s goals and supportive care needs. Participants in all streams will be provided with a patient diary to record hospitalizations, emergency department presentations and any other events or encounters they deem of significance. This diary will be reviewed at each scheduled visit.