Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma

NCT04999085 | Completed Results DMC

• 2 other identifiers: LCCC 21012021YIA-7316118933
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Myeloma is the second most common type of blood cancer in the United States. Myeloma most commonly affects older adults. While some younger individuals do get myeloma, the average age when people are first diagnosed with myeloma is around 69 to 70. Along with having a higher risk for myeloma, older adults have an increased chance of developing other health problems or issues. However, not everyone ages in the same way. Some older adults experience major changes in health or degree of independence at relatively younger ages, while others remain quite healthy for many years. The specific issues that develop with age can also vary from person to person. One older adult may face difficulties with vision or hearing, while another may develop memory problems. Historically, cancer doctors have not done a very good job identifying these non-cancer issues. As a result, research has focused on better ways to systematically pick up on issues that may impact cancer outcomes or quality of life. The outgrowth of this research is assessments and questionnaires referred to as "comprehensive geriatric assessments," which evaluate the health and functionality of older adults thoroughly but efficiently. In both myeloma and other types of cancer, problems identified through geriatric assessments have been shown to predict how likely people are to develop side effects of cancer treatment and predict how long people are likely to live with cancer. Prior research has not addressed how best to help with the issues picked up through a geriatric assessment among patients undergoing treatment for myeloma, although a number of effective interventions have been shown to benefit older adults with similar problems in other settings. Therefore, the current study will test a strategy of systematically screening older adults undergoing myeloma treatment for geriatric-assessment-related deficits and referring participants to appropriate services and resources. The geriatric assessment in this study includes tests of mobility, memory, vision, hearing, and nutrition as well as questions about symptoms and social support. Individuals who have deficits in one of these areas will be referred to relevant services and resources such as physical therapy, a pharmacist, or the cancer center support program. They will then repeat the same assessment three months later, and the results will be compared to their original assessment to see if the deficit has improved, with particular attention to mobility and social support.

Conditions

Multiple Myeloma; Myeloma; Disability Physical; Disabilities Multiple

Keywords

Geriatric assessment; Supportive care; Disability; Functional assessment

Outcome Measures

Primary Outcomes (1)

• Intervention Attendance (Feasibility)

  Attendance at at least one appointment for a specialty / supportive care resource to which the subject is referred. The result is reported as the number of participants who attend at least one such appointment.

  Up to 3 months from enrollment

Secondary Outcomes (1)

• Subject Satisfaction With Program (Acceptability)

  3 months from enrollment

Study Arms (1)

Supportive Care

EXPERIMENTAL

Other: Supportive care interventions

Interventions

Supportive care interventions OTHER

Subjects will be referred to specialists and/or supportive care interventions based on issues/deficits identified on a baseline geriatric assessment. These interventions will be selected based on deficits or problems identified on baseline assessments. These include referral to physical/occupational therapy for those with physical deficits (Activities of Daily Living impairment, Instrumental Activities of Daily Living impairment, Timed Up and Go, or falls), to optometry/ophthalmology (for visual impairment), to audiology (for hearing impairment), to pharmacist (for polypharmacy), and to cancer center support program (for Mental Health Index 13 criteria).

Supportive Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 60 years or older with a confirmed diagnosis of multiple myeloma currently undergoing or planned to begin treatment for multiple myeloma.
• Enrollment in an existing registry of individuals with plasma cell disorder (ClinicalTrials.gov identifier NCT03717844; institutional protocol # LCCC1728)
• Be willing and capable of providing informed consent.
• Presence of at least one intervenable deficit on the most recent registry assessment:
• Activities of daily living score \< 14.
• Instrumental activities of living score \< 14.
• Timed Up and Go test = 14 seconds (or unable to complete the test).
• One fall in the prior 6 months.
• Eyesight poor or worse.
• Hearing poor or worse.
• Number of daily medications 10 or greater.
• Mental Health Index-13 Depression score 12 or greater.
• Mental Health Index-13 Anxiety score 6 or greater.

You may not qualify if:

• Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Conquer Cancer Foundation: collaborator

Study Sites (1)

The N.C. Cancer Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• University of North Carolina (UNC) Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Christopher E. Jensen, MD, MSCR
• Organization: University of North Carolina Lineberger Comprehensive Cancer Center

cejensen@med.unc.edu

+1 984-987-1072

Study Officials

• Christopher E Jensen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm pilot study of supportive care interventions

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: December 1, 2021
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: February 28, 2025
• Results First Posted: September 25, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)