Multiple Myeloma (MM) Quality of Life (QOL) Study
Quality of Life and Psychological Distress in Patients With Multiple Myeloma and Their Caregivers
1 other identifier
observational
360
1 country
3
Brief Summary
The main purpose of this study is to examine differences in quality of life and psychological distress for both Multiple Myeloma patients receiving treatment and their caregivers and to assess patient and caregiver prognostic understanding (understanding of the likely course of a disease over time) of Multiple Myeloma to guide development of more personalized treatment plans. This study looks to further understand quality of life changes throughout multiple myeloma therapy for both patients and caregivers to help determine ways to improve patient and caregiver understanding of illness and in turn, tailor customized treatment that best aligns with patient preferences. The study will use a series of questionnaires to measure quality of life, mood, coping strategies, and prognostic understanding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2022
CompletedMay 14, 2020
May 1, 2020
1.5 years
May 12, 2020
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life (QOL) Patient Description
Describe patient QOL scores by lines of therapy. Functional Assessment of Cancer Therapy-Multiple Myeloma(FACT-MM) will be used to assess QOL, which has been validated for use in multiple care settings.\[10\]. The FACT-MM consists of four subscales assessing well-being across four domains (physical, functional, emotional, and social). These self-reported measures possess strong psychometric properties and have been validated for patients with cancer \[Appendix E\].
Up to 1 year
Quality of life (QOL) Caregiver Description
Describe cargiver QOL scores by associated patient line of therapy
Up to 1 year
Secondary Outcomes (12)
QOL-Functional Assessment
Up to 1 year
Patient Burden Assessment-ESAS
Up to 1 year
Patient Fatigue Symptoms
Up to 1 year
Patient anxiety symptoms
Up to 1 year
Patient Depression symptoms
Up to 1 year
- +7 more secondary outcomes
Study Arms (3)
Newly Diagnosed MM 1st Line and Caregivers
This research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires. * Patients will be asked to identify a caregiver (e.g. a relative or friend) upon whom they rely for help and has an in-person contact with the patient at least 2x per week. * Both patients with or without identified caregivers will complete a one time series of questionnaires. * The questionnaires are completed one time only and measure quality of life, mood, coping strategies, and prognostic understanding and can be completed in the hospital, clinic, over the email, or telephone with assistance provided as needed.Questionnaires take approximately 20 minutes to complete.
MM receiving 1-3 prior lines of therapy and Caregivers
This research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires. * Patients will be asked to identify a caregiver (e.g. a relative or friend) upon whom they rely for help and has an in-person contact with the patient at least 2x per week. * Both patients with or without identified caregivers will complete a one time series of questionnaires. * The questionnaires are completed one time only and measure quality of life, mood, coping strategies, and prognostic understanding and can be completed in the hospital, clinic, over the email, or telephone with assistance provided as needed.Questionnaires take approximately 20 minutes to complete
MM patients receiving ≥ 4 lines of therapy and Cargivers
This research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires. * Patients will be asked to identify a caregiver (e.g. a relative or friend) upon whom they rely for help and has an in-person contact with the patient at least 2x per week. * Both patients with or without identified caregivers will complete a one time series of questionnaires. * The questionnaires are completed one time only and measure quality of life, mood, coping strategies, and prognostic understanding and can be completed in the hospital, clinic, over the email, or telephone with assistance provided as needed.Questionnaires take approximately 20 minutes to complete
Interventions
Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.
Eligibility Criteria
Patients receiving therapy for Multiple Myeloma and their identified/designated caregivers.
You may qualify if:
- Patient Eligibility criteria:
- Adult patients (greater than 18 years) receiving active therapy for MM.
- For patients with newly diagnosed MM, patients are eligible while undergoing induction therapy prior to received autologous stem cell transplant but not after.
- Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter.
- Caregiver Eligibility criteria:
- Adult (greater than 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week.
- Ability to read and respond to questions in English or to complete questionnaires with minimal assistance of an interpreter
You may not qualify if:
- Patients receiving maintenance therapy only.
- Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Kully Family Foundationcollaborator
Study Sites (3)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth K O'Donnell, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 14, 2020
Study Start
June 1, 2020
Primary Completion
November 15, 2021
Study Completion
May 16, 2022
Last Updated
May 14, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.