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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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:

  • - Patient

    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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04388735
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Elizabeth K O'Donnell, MD
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Quality of Life, Symptom, Behavioral
Additional Details

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.

Arms & Interventions

Arms

: 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

Behavioral: - Questionnaire

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Site Contact

Elizabeth K O'Donnell, MD

ekodonnell@mgh.harvard.edu

617-643-2517

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Site Contact

Jacalyn Rosenblatt, MD

jrosenb1@bidmc.harvard.edu

617-667-9920

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Omar Nadeem, MD

Omar_Nadeem@DFCI.HARVARD.EDU

617-658-6000