Improving quality of life for older patients with frailty and blood cancer
Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment and Treatment; A Randomized Controlled Trial. IMPROVE
This study is testing if adding a special assessment and treatment plan to regular care can help older, frail patients with blood cancer feel better and improve their daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense C) |
| Trial ID | NCT06373471 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of adding a comprehensive geriatric assessment (CGA) and treatment to the standard care for older, frail patients diagnosed with hematological cancer. A total of 152 participants will be randomly assigned to either receive the CGA intervention alongside their cancer treatment or continue with standard care alone. The primary goal is to evaluate the impact of this intervention on the elderly functional index after 12 weeks. The study aims to enhance treatment adherence and manage complications associated with frailty in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 70 and older who have a new diagnosis or progression of specific hematological malignancies and exhibit frailty.
Not a fit: Patients currently undergoing systemic treatment for other cancers or those requiring specialized neuro-rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and treatment outcomes for older patients with frailty and hematological cancer.
How similar studies have performed: Other studies have shown promising results with similar comprehensive geriatric assessment approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Odense C
- Odense University Hospital — Odense C, Denmark (Recruiting)
Study contacts
- Principal investigator: Henrik Frederiksen — Odense University Hospital
- Study coordinator: Henrik Frederiksen
- Email: henrik.frederiksen@rsyd.dk
- Phone: +45 21849307
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.