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

Primary Purpose

Multiple Myeloma, Myeloma, Disability Physical

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supportive care interventions
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Geriatric assessment, Supportive care, Disability, Functional assessment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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.

Sites / Locations

  • The N.C. Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 2, 2021
Last Updated
August 16, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Conquer Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04999085
Brief Title
Geriatric-assessment Interventions to Address Functional Deficits in Older Adults w Multiple Myeloma
Official Title
Geriatric-assessment-guided Interventions to Address Functional Deficits in Older Adults Undergoing Treatment for Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
August 4, 2023 (Actual)
Study Completion Date
August 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Conquer Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Myeloma, Disability Physical, Disabilities Multiple
Keywords
Geriatric assessment, Supportive care, Disability, Functional assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm pilot study of supportive care interventions
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Supportive care interventions
Intervention Description
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).
Primary Outcome Measure Information:
Title
Intervention attendance (feasibility)
Description
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.
Time Frame
3 months from enrollment
Secondary Outcome Measure Information:
Title
Subject satisfaction with program (acceptability)
Description
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.
Time Frame
3 months from enrollment
Other Pre-specified Outcome Measures:
Title
European Organization for Research and Treatment of Cancer (EORTC) Physical Function scores
Description
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.
Time Frame
3 months from enrollment
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation score
Description
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.
Time Frame
3 months from enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher E Jensen, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
The N.C. Cancer Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://unclineberger.org
Description
University of North Carolina (UNC) Lineberger Comprehensive Cancer Center

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

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