Frailty, Hematologic Malignancy, Quality of Life, Treatment Adherence, Treatment Complication
Conditions
Keywords
Comprehensive Geriatric Assessment
Brief summary
The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks.
Detailed description
RESEARCH PLAN STUDY DESIGN IMPROVE aims to investigate the efficacy of adding comprehensive geriatric assessment (CGA) and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention CGA and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation as well as management of comorbidity, frailty and needs as is the current standard at Departments of Hematology. PARTICIPANTS AND TIMELINES One hundred and fifty two patients complying with inclusion and exclusion criteria detailed below will be recruited at participating Hematological Departments in Denmark. Study period is 52 weeks for each study participant. INTERVENTIONS AND ASSESSMENTS Hematological treatment plan Study participants will be given a hematological cancer treatment plan according to standard guidelines at the discretion of the treating physician at the Department of Hematology. The hematological treatment plan will not be altered because of participation in IMPROVE study. Data on whether the cancer treatment is prescribed with a reduced dose-intensity due to frailty or later reduced due to toxicity will be collected. CGA and treatment CGA and treatment will be performed before or after initiation of hematological cancer treatment, and within 6 weeks from inclusion. Performing CGA shall not delay initiation of hematological cancer treatment if immediate treatment is necessary. A geriatrician together with a geriatric nurse will perform CGA at the Department of Geriatric Medicine. CGA is more thoroughly described elsewhere in this report. Based on CGA findings, the geriatrician will initiate relevant further investigation(s), intervention(s) and treatment(s) if indicated. Assessment of functional status The investigators will record the patients exercise habits via a short interview with the patient. The interview contains two questions concerning exercise habits derived from the Survey of Health, Ageing and Retirement in Europe (SHARE). Furthermore objective simple physical muscle strength tests will be applied to assess upper and lower extremity functioning. Physical tests Physical tests will be assessed at baseline and at 12 and 26 weeks follow-up. Physical tests will be 30 seconds chair stand test (30s-CST) and handgrip strength Treatment toxicity and adherence to the hematological treatment plan Data will be collected at the beginning of each treatment cycle until 26 weeks after inclusion. The following data will be collected: * Treatment type. * Whether the treatment is a standard regimen, a dose-intensity reduced regimen or a study treatment from another clinical trail. * Whether the hematological treatment plan has been changed, including reduction of dosage, delay of treatment or preterm end of treatment and the reason for change of treatment plan. * Treatment toxicity using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCICTCAE v5.0) for selected groups of toxicity * Date and reason for discontinuation of cancer treatment until treatment completion or 26 weeks after initiation, whichever comes first. Review of medications Information about polypharmacy (more than 5 daily drugs) will be collected from patients´ personal electronic file of prescriptions and medication purchases at baseline and at 12- and 26-week follow-up. Hospitalization and survival Patients will be followed through a review of medical records for number and duration of unplanned hospitalizations and overall, and cancer-specific survival at 26- and 52-week follow-up.
Interventions
OTHERComprehensive geriatric assessment (CGA) and treatment
CGA and treatment is as an outpatient evaluation by a geriatric medical specialist and nurse. Specific CGA components in this study include: * Assessment of comorbidity and treatments * Review of medications including potential adjustment * Assessment of current symptoms and health related issues including geriatric syndromes such as depression, dementia, delirium, nutritional problems, falls and fatigue * Objective examination including blood tests and electrocardiogram * Assessment of activities of daily living (ADL) and instrumental ADL through standardized questionnaires * Assessment of domestic conditions, including need for assistance * Assessment of physical function Based on findings, the geriatrician will initiate relevant interventions and follow-up as required
Sponsors
Velux Fonden
Danish Cancer Research Foundation
The Dagmar Marshall Foundation
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥70 years * New diagnosis or progression/relapse of acute leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myelomonocytic leukemia or myelofibrosis * Scheduled systemic cancer treatment or initiated systemic cancer treatment within 6 weeks * Geriatric 8 frailty score of ≤14 at screening * Life expectancy \> 6 months * Not hospitalized at the time of inclusion
Exclusion criteria
* Current systemic treatment for other coexisting cancer. Patients receiving anti-hormone treatment for breast cancer or prostate cancer are not excluded, if no evidence of disease progression (radiological/biochemical) in past 3 months or if treatment is adjuvant. * Having consulted a geriatric outpatient clinic past 6 months * Patients in need of specialized neuro-rehabilitation * Unable to understand Danish * Unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elderly functional Index | 12 and 26 weeks after inclusion | The Elderly Functional Index (ELFI) is calculated using the physical functioning, role functioning, and social functioning of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) core 30, and the mobility item of the EORTC-QLQ-elderly 14 (ELD14) questionnaire. ELFI is calculated at baseline and at 12- and 26- week follow-up. Maximum value of ELFI is 100. Minimum value of ELFI is 0. Higher score indicates higher function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14). | 12 and 26 weeks after inclusion | The questionnaire contains functional scales and symptom scales. Maximum value for scales is 100 and minimum values is 0. A higher score indicates higher function for functional scales and more symptoms for symptom scales |
| Handgrip strength | 12 and 26 weeks after inclusion | Handgrip strength is measured in kilograms with a handgrip dynamometer |
| 30-second chair stand test | 12 and 26 weeks after inclusion | 30-second chair stand test is measured in number of stand-up-and-sit-downs in 30 seconds |
| Treatment toxicity | Baseline, 12 and 26 weeks after inclusion | Endpoint is assessed as prevalence of grade \> 1 adverse events according to Common Terminology Criteria for Adverse Events Version 5.0 at baseline, 12 and 26 weeks after inclusion |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). | 12 and 26 weeks after inclusion | The questionnaire contains functional and symptom subscales. Maximum value for scales is 100 and minimum values is 0. A higher score indicates higher function for functional scales and more symptoms for symptom scales. |
| Polypharmacy yes/no | 12 and 26 weeks after inclusion | Polypharmacy is defined as use of 5 or more daily medications |
| Unplanned hospital admissions | 26 and 52 weeks after inclusion | rates and hospital days |
| Overall and cancer specific survival | 26 and 52 weeks after inclusion | survival proportion and cancer specific survival proportion |
| Adherence to hematological cancer treatment | 12 and 26 weeks after inclusion | Alterations to original cancer treatment plan yes/no |
Countries
Denmark
Contacts
Primary ContactHenrik Frederiksen
Backup ContactNina Andersen
Outcome results
None listed