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

November 12, 2024 updated by: Odense University Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Odense C
      • Odense, Odense C, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm pilot study. Intervention: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inclusion rate
Time Frame: 12 weeks
succes defined as three participants/month
12 weeks
Completion of intervention
Time Frame: 12 weeks
Success: 80% of study participants complete CGA within 6 weeks from inclusion
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Study Director: Henrik Frederiksen, Consultant, professor, Department of Hematology, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Actual)

July 3, 2023

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFE-X 22.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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