Hematological CancersIMPROVE pilotNCT06689332
Improving Quality of Life in Frail, Older Patients with Hematological Cancer Through Geriatric Assessment and Treatment - a Pilot Study
A study testing Comprehensive Geriatric Assessment in people with Hematological Cancers and Frailty, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hematological Cancers, Frailty, ELDERLY PEOPLE
- What is being tested?
- Comprehensive Geriatric Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Sep 2022to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years
- Diagnosis with 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
- Life expectancy > 3 months
- Geriatric 8 score of ≤14 at screening
Who cannot join
- Current systemic treatment for other coexisting cancer. Patients receiving anti-hormone treatment for breast- 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
- Unable to understand Danish
- Unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Comprehensive Geriatric Assessment
- Keywords
- Pilot study, feasibility study, frailty in hematological cancer, comprehensive geriatric assessment, intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm pilot study. Intervention: Comprehensive geriatric assessment. | Experimental | 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. Receives: Other: Comprehensive Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclusion rate
succes defined as three participants/month
Measured: 12 weeks
Completion of intervention
Success: 80% of study participants complete CGA within 6 weeks from inclusion
Measured: 12 weeks
Participant retention
Success: ≥80% of study participants complete study activities and 12 weeks of follow-up among partici-pants still alive
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start21 Sep 2022
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological CancersStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Frederiksen, Consultant, professor, Study director, Department of Hematology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689332
- Sponsor's protocol ID
- HFE-X 22.18
- Acronym
- IMPROVE pilot
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life in Frail, Older Patients with Hematological Cancer Through Geriatric Assessment and Treatment - a Pilot Study
- ClinicalTrials.gov ID
- NCT06689332
- Acronym / sponsor ID
- IMPROVE pilot / HFE-X 22.18
- Conditions
- Hematological Cancers, Frailty, ELDERLY PEOPLE
- Keywords
- Pilot study, feasibility study, frailty in hematological cancer, comprehensive geriatric assessment, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm pilot study. Intervention: Comprehensive geriatric assessment. | Experimental | Other: Comprehensive Geriatric AssessmentComprehensive 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥70 years
- Diagnosis with 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
- Life expectancy > 3 months
- Geriatric 8 score of ≤14 at screening
Key exclusion criteria (4 listed)
- Current systemic treatment for other coexisting cancer. Patients receiving anti-hormone treatment for breast- 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
- Unable to understand Danish
- Unable to give written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentComprehensive 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. | Other | Single arm pilot study. Intervention: Comprehensive geriatric assessment. |
Primary outcome
Inclusion rate
Time frame: 12 weeks
succes defined as three participants/month
Completion of intervention
Time frame: 12 weeks
Success: 80% of study participants complete CGA within 6 weeks from inclusion
Participant retention
Time frame: 12 weeks
Success: ≥80% of study participants complete study activities and 12 weeks of follow-up among partici-pants still alive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Frederiksen, Consultant, professor study director
Department of Hematology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Geriatric Assessment in people with Hematological Cancers and Frailty, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion rate (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.