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

Multiple Myeloma Clinical Trial

Official title:

Geriatric-assessment-guided Interventions to Address Functional Deficits in Older Adults Undergoing Treatment for Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999085
• Other study ID #: LCCC 2101
• Secondary ID: 2021YIA-73161189
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: August 4, 2023

Study information

• Verified date: May 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

STUDY OUTLINE

Study participants complete a baseline Geriatric Assessment and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ) Core 30 (C30) and Myeloma supplement (MY20) questionnaires, either at the time of enrollment or as part of previous research studies.

Based on these assessments, an intervention strategy is developed by Study Team. These interventions largely consist of referrals to relevant specialists and existing services. These recommendations are communicated to the study participant, and participant-approved intervention referrals are made.

Following an initial appointment with these specialists, further follow-up will be determined based on the subject and specialist without input from the Study Team.

At three months from enrollment, study participants will be asked to complete a follow-up geriatric assessment, repeat EORTC questionnaires, and a satisfaction /feedback survey.

Duration of Therapy:

For patients referred to specialists as above, the duration of treatment or care with the specialist will be determined based on an agreement between the specialist and study participant.

Duration of Follow-up:

As part of this study, participants will only be followed through the three-month follow-up assessment described above. For subjects participating in or recruited from other research studies, follow-up according to those other protocols will continue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Disabilities Multiple
• Disability Physical
• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Supportive care interventions
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).

Locations

Country	Name	City	State
United States	The N.C. Cancer Hospital	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	European Organization for Research and Treatment of Cancer (EORTC) Physical Function scores	Preliminary efficacy with respect to physical function will be evaluated via changes in EORTC Quality of Life of Cancer Patients (C30) questionnaire physical function scores. The change in mean score from baseline to 3 month follow up among study participants will be reported.	3 months from enrollment
Other	Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation score	Preliminary efficacy with respect to psychosocial function will be evaluated via changes in PROMIS Social Isolation score (evaluated using Social Health v2.0 instruments- Social Isolation 4a). The change in mean score from baseline to 3 month follow up among study participants will be reported.	3 months from enrollment
Primary	Intervention attendance (feasibility)	Attendance at at least one appointment for a specialty / supportive care resource to which the subject is referred. This will be reported as the percentage of participants who attend at least one such appointment.	3 months from enrollment
Secondary	Subject satisfaction with program (acceptability)	Subject satisfaction with the intervention program, which will be assessed by a single-item 5-point Likert scale response, with higher scores indicating greater satisfaction. The mean score reported by study participants will be reported.	3 months from enrollment

External Links

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