Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373471
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-04
Brief Title:
Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment A Randomized Controlled Trial IMPROVE
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
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 11 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 11 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 investigations interventions and treatments 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 50 NCICTCAE v50 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
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 11 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 investigations interventions and treatments 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 50 NCICTCAE v50 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None