Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT06689332
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2024-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Quality of Life in Frail, Older Patients with Hematological Cancer Through Geriatric Assessment and Treatment - a Pilot Study
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
Improving Quality of Life in Frail, Older Patients with Hematological Cancer Through Geriatric Assessment and Treatment - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE pilot
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: