Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment

NCT06373471 | Recruiting

• 1 other identifier: S-20230101
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks.

Conditions

Hematologic Malignancy; Treatment Adherence; Treatment Complication; Frailty; Quality of Life

Keywords

Comprehensive Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

• Elderly functional Index

  The Elderly Functional Index (ELFI) is calculated using the physical functioning, role functioning, and social functioning of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) core 30, and the mobility item of the EORTC-QLQ-elderly 14 (ELD14) questionnaire. ELFI is calculated at baseline and at 12- and 26- week follow-up. Maximum value of ELFI is 100. Minimum value of ELFI is 0. Higher score indicates higher function.

  12 and 26 weeks after inclusion

Secondary Outcomes (9)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

  12 and 26 weeks after inclusion

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14).

  12 and 26 weeks after inclusion

• Handgrip strength

  12 and 26 weeks after inclusion

• 30-second chair stand test

  12 and 26 weeks after inclusion

• Treatment toxicity

  Baseline, 12 and 26 weeks after inclusion

Study Arms (2)

Intervention arm

EXPERIMENTAL

Comprehensive Geriatric Assessment and treatment

Other: Comprehensive geriatric assessment (CGA) and treatment

Control

NO INTERVENTION

Standard hematological evaluation of comorbidity and needs during hematological cancer treatment.

Interventions

Comprehensive geriatric assessment (CGA) and treatment OTHER

CGA and treatment is as an outpatient evaluation by a geriatric medical specialist and nurse. Specific CGA components in this study include: * Assessment of comorbidity and treatments * Review of medications including potential adjustment * Assessment of current symptoms and health related issues including geriatric syndromes such as depression, dementia, delirium, nutritional problems, falls and fatigue * Objective examination including blood tests and electrocardiogram * Assessment of activities of daily living (ADL) and instrumental ADL through standardized questionnaires * Assessment of domestic conditions, including need for assistance * Assessment of physical function Based on findings, the geriatrician will initiate relevant interventions and follow-up as required

Intervention arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Velux Fonden: collaborator
• Danish Cancer Research Foundation: collaborator
• The Dagmar Marshall Foundation: collaborator

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Treatment Adherence and Compliance; Frailty

Interventions

Geriatric Assessment; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Henrik Frederiksen

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Frederiksen

CONTACT

+45 21849307; henrik.frederiksen@rsyd.dk

Nina Andersen

CONTACT

+45 40437488; nina.andersen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: April 2, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)