Multiple Myeloma (MM) Quality of Life (QOL) Study

NCT ID: NCT04388735

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-05-16

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.

Detailed Description

This research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires.

• It is expected that about 180 people undergoing treatment for multiple myeloma and up to 180 of their caregivers will take part in this research study.

-- 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.

Conditions

Multiple Myeloma; Quality of Life; Symptom, Behavioral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Questionnaire

Intervention Type: BEHAVIORAL

Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.

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

Questionnaire

Intervention Type: BEHAVIORAL

Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.

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

Questionnaire

Intervention Type: BEHAVIORAL

Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.

Interventions

Questionnaire

Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kully Family Foundation

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth O'Donnell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth K O'Donnell, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Elizabeth K O'Donnell, MD

Role: CONTACT

ekodonnell@mgh.harvard.edu

617-643-2517

Facility Contacts

Elizabeth K O'Donnell, MD

Role: primary

ekodonnell@mgh.harvard.edu

617-643-2517

Jacalyn Rosenblatt, MD

Role: primary

jrosenb1@bidmc.harvard.edu

617-667-9920

Omar Nadeem, MD

Role: primary

Omar_Nadeem@DFCI.HARVARD.EDU

617-658-6000

Other Identifiers

19-816

Identifier Type: -

Identifier Source: org_study_id