MedTrace Logo

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

NCT06373471 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Hematologic Malignancy
  • Treatment Adherence
  • Treatment Complication
  • Frailty
  • Quality of Life

Interventions

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

Sponsors & Collaborators

  • Velux Fonden

    collaborator OTHER

  • Danish Cancer Research Foundation

    collaborator OTHER

  • The Dagmar Marshall Foundation

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Henrik Frederiksen · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06373471 on ClinicalTrials.gov