Trial Outcomes & Findings for Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma (NCT NCT04999085)

Last Updated: 2025-02-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Up to 3 months from enrollment

Results posted on

2025-02-28

Participant Flow

Participants were recruited from 11/15/2021 through 05/04/2023 at one cancer center in North Carolina. Subjects were enrolled in the study between 12/01/2021 - 12/15/2022.

Subjects were enrolled in the study between 12/01/2021- 12/15/2022, at one cancer center in the United States. A total of 16 participants consented, were found eligible, and started to study.

Participant milestones

Participant milestones
Measure	Supportive Care 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).
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Supportive Care 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).
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Supportive Care n=16 Participants 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).
Age, Continuous	75.69 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months from enrollment

Population: Subjects who started the study completed at least one study intervention.

Outcome measures

Outcome measures
Measure	Supportive Care n=16 Participants 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).
Intervention Attendance (Feasibility)	50 percentage of participants

SECONDARY outcome

Timeframe: 3 months from enrollment

Population: Subjects who started the study completed study interventions and followed up 3 months.

Subject satisfaction with the intervention program, will be assessed by a single-item 5-point from 1 to 5, Likert scale response, with higher scores indicating greater satisfaction and lower scores indicating less satisfaction. The mean score reported by study participants will be reported.

Outcome measures

Outcome measures
Measure	Supportive Care n=15 Participants 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).
Subject Satisfaction With Program (Acceptability)	4.4 score on a scale Interval 3.7 to 5.0

Adverse Events

Supportive Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher E. Jensen, MD, MSCR

University of North Carolina Lineberger Comprehensive Cancer Center

Phone: +1 984-987-1072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place