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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04999085

Collaborator

Conquer Cancer Foundation (Other)

Enrollment

Location

Arm

7.5

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Myeloma Disability Physical Disabilities Multiple	Other: Supportive care interventions	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm pilot study of supportive care interventionsSingle-arm pilot study of supportive care interventions

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supportive Care	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).

Arm

Intervention/Treatment

Experimental: Supportive Care

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).

Outcome Measures

Primary Outcome Measures

Intervention attendance (feasibility) [3 months from enrollment]
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.

Secondary Outcome Measures

Subject satisfaction with program (acceptability) [3 months from enrollment]
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.

Other Outcome Measures

European Organization for Research and Treatment of Cancer (EORTC) Physical Function scores [3 months from enrollment]
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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation score [3 months from enrollment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.