NCT06689332

Improving Quality of Life in Frail, Older Patients with Hematological Cancer Through Geriatric Assessment and Treatment - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Purpose of the Study This study aims to assess the feasibility of conducting outpatient geriatric health assessment (comprehensive geriatric assessment - CGA) alongside initiation of hematological cancer treatment in frail older adults aged 70 or older, diagnosed with hematological cancer. Methods This is a pilot study, conducted in preparation for a larger randomized trial (not detailed here). The study will enroll 15 frail patients aged 70 or older, diagnosed with treatment-requiring hematological cancer. Frailty will be assessed using the Geriatric 8 (G8) scoring system, consisting of eight questions, with a score of 14 or below categorizing a patient as frail. Each of the 15 included patients will undergo a CGA concurrently with the start of cancer treatment. This assessment will be conducted by a specialist in geriatric medicine and will include reviews of existing symptoms and comorbidities, cognitive and physical functioning, depressive symptoms, nutritional needs, daily living assistance requirements, and medication usage. The health assessment will involve patient interviews, physical exams, basic physical tests, blood tests, and an electrocardiogram (ECG). Depending on the assessment findings, suitable interventions such as medication adjustments, referrals to physical therapy/rehabilitation, nutritional counseling, or evaluation and treatment for other conditions (e.g., dementia, depression) may be initiated. The geriatric health assessment will not alter the cancer treatment plan. Study Participants Inclusion Criteria * Patients aged 70 or older * Treatment-requiring hematological cancer * Frailty score (G8) of 14 or lower * Expected survival \> 3 months * Must be able to understand spoken and written information in Danish. Exclusion Criteria * Geriatric outpatient consultation within the last 6 months * Ongoing treatment for another type of cancer, except anti-hormone therapy for stable breast or prostate cancer * Inability to provide informed consent. Side Effects, Risks, and Disadvantages The study entails minimal risks and inconveniences. Participants will receive standard hematological cancer treatment and a CGA, a well-established standard procedure within geriatric medicine. A disadvantage may be the need for an additional hospital visit for the CGA. Where feasible, appointments will be coordinated between the hematological and geriatric departments. Additional blood tests and an ECG may also be required if these are not part of the cancer treatment regimen. Minor muscle soreness could occur in participants referred to physical therapy. Scientific and Ethical Considerations This study is expected to pose minimal inconvenience for participants (mentioned above). The study has the potential to enhance the cancer treatment course for participants by reducing functional decline, improving quality of life, and minimizing treatment side effects, thereby increasing adherence to cancer therapy. Additionally, the study will contribute valuable knowledge for designing a subsequent randomized trial, investigating how to improve cancer treatment and care for older, frail patients with hematological cancers, while preserving their quality of life and functional abilities.

Conditions

• Hematological Cancers
• Frailty
• ELDERLY PEOPLE

Interventions

Type	Name	Description
OTHER	Comprehensive Geriatric Assessment	Comprehensive geriatric assessment (CGA) is performed by a geriatrician and a geriatric nurse. CGA in this study includes: Assessment of coexisting diseases and treatments. Review of medications and adjustments as needed. Assessment of symptoms and health related issues including screening for depression, dementia, delirium, nutritional problems, falls, polypharmacy and fatigue. Objective examination including blood tests and electrocardiogram. Assessment of activities of daily living and instrumental activities of daily living through standardized questionnaires. Assessment of domestic conditions, including need for assistance from community-based health care services. Assessment of physical function through history and physical tests. Based on the CGA findings, the geriatrician will initiate relevant interventions (including investigations or treatments) and follow-up as required.

Timeline

• Start date: 2022-09-21
• Primary completion: 2023-07-03
• Completion: 2023-07-03
• First posted: 2024-11-14
• Last updated: 2024-11-14

Locations

1 site across 1 country: Denmark