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

Mass General Brigham

Status: Unknown

Conditions: Multiple Myeloma; Quality of Life; Symptom, Behavioral

Treatments: Behavioral: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04388735

19-816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

360 participants in 3 patient groups

Newly Diagnosed MM 1st Line and Caregivers

Description:

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.

Treatment:

Behavioral: Questionnaire

MM receiving 1-3 prior lines of therapy and Caregivers

Description:

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

Treatment:

Behavioral: Questionnaire

MM patients receiving ≥ 4 lines of therapy and Cargivers

Description:

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

Treatment:

Behavioral: Questionnaire