Clinical trial NCT04388735: Multiple Myeloma (MM) Quality of Life (QOL) Study
Official title: Quality of Life and Psychological Distress in Patients With Multiple Myeloma and Their Caregivers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Quality of Life
Symptom, Behavioral
Keywords: Multiple Myeloma
Quality of Life
Symptom, Behavioral
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Kully Family Foundation
First posted: 2020-05-14
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving therapy for Multiple Myeloma and their identified/designated caregivers.

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.

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:

* 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.

Primary outcomes:
measure: Quality of life (QOL) Patient Description
timeFrame: Up to 1 year
measure: Quality of life (QOL) Caregiver Description
timeFrame: Up to 1 year
Secondary outcomes:
measure: QOL-Functional Assessment
timeFrame: Up to 1 year
measure: Patient Burden Assessment-ESAS
timeFrame: Up to 1 year
measure: Patient Fatigue Symptoms
timeFrame: Up to 1 year
measure: Patient anxiety symptoms
timeFrame: Up to 1 year
measure: Patient Depression symptoms
timeFrame: Up to 1 year
measure: Patient Post-traumatic stress symptoms
timeFrame: Up to 1 year
measure: Patient coping
timeFrame: Up to 1 year
measure: Caregiver Quality of Life (QOL)
timeFrame: Up to 1 year
measure: Caregiver Burden
timeFrame: Up to 1 year
measure: Caregiver anxiety
timeFrame: Up to 1 year
measure: Caregiver Depression
timeFrame: Up to 1 year
measure: Caregiver Coping
timeFrame: Up to 1 Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth K O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: