Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment (IMPROVE)

Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Frailty; Treatment Adherence; Hematologic Malignancy; Treatment Complication
• Intervention / Treatment: Other: Comprehensive geriatric assessment (CGA) and treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik Frederiksen; Phone Number: +45 21849307; Email: henrik.frederiksen@rsyd.dk
• Study Contact Backup: Name: Nina Andersen; Phone Number: +45 40437488; Email: nina.andersen@rsyd.dk

Study Locations

• Denmark
  • Odense C, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Nina Andersen, M.D.; Phone Number: +4540437488; Email: nina.andersen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Comprehensive Geriatric Assessment and treatment	Other: Comprehensive 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
No Intervention: Control; Standard hematological evaluation of comorbidity and needs during hematological cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elderly functional Index	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.	12 and 26 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).	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.	12 and 26 weeks after inclusion
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14).	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	12 and 26 weeks after inclusion
Handgrip strength	Handgrip strength is measured in kilograms with a handgrip dynamometer	12 and 26 weeks after inclusion
30-second chair stand test	30-second chair stand test is measured in number of stand-up-and-sit-downs in 30 seconds	12 and 26 weeks after inclusion
Treatment toxicity	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	Baseline, 12 and 26 weeks after inclusion
Adherence to hematological cancer treatment	Alterations to original cancer treatment plan yes/no	12 and 26 weeks after inclusion
Polypharmacy yes/no	Polypharmacy is defined as use of 5 or more daily medications	12 and 26 weeks after inclusion
Unplanned hospital admissions	rates and hospital days	26 and 52 weeks after inclusion
Overall and cancer specific survival	survival proportion and cancer specific survival proportion	26 and 52 weeks after inclusion

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Velux Fonden; The Dagmar Marshall Foundation; Danish Cancer Research Foundation
• Investigators: Principal Investigator: Henrik Frederiksen, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Comprehensive Geriatric Assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Frailty
• Other Study ID Numbers: S-20230101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD sharing plan is to assess the possibility of publishing IPD or part of IPD in a way that is allowed taken GDPR into account.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No