Clinical trial NCT06373471: Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment
Official title: Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Treatment Adherence
Treatment Complication
Frailty
Quality of Life
Keywords: Comprehensive Geriatric Assessment
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Velux Fonden
name: Danish Cancer Research Foundation
name: The Dagmar Marshall Foundation
First posted: 2024-04-18
Enrollment: 152
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Elderly functional Index
timeFrame: 12 and 26 weeks after inclusion
Secondary outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
timeFrame: 12 and 26 weeks after inclusion
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14).
timeFrame: 12 and 26 weeks after inclusion
measure: Handgrip strength
timeFrame: 12 and 26 weeks after inclusion
measure: 30-second chair stand test
timeFrame: 12 and 26 weeks after inclusion
measure: Treatment toxicity
timeFrame: Baseline, 12 and 26 weeks after inclusion
measure: Adherence to hematological cancer treatment
timeFrame: 12 and 26 weeks after inclusion
measure: Polypharmacy yes/no
timeFrame: 12 and 26 weeks after inclusion
measure: Unplanned hospital admissions
timeFrame: 26 and 52 weeks after inclusion
measure: Overall and cancer specific survival
timeFrame: 26 and 52 weeks after inclusion
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Henrik Frederiksen
role: PRINCIPAL_INVESTIGATOR
References: