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

Multiple Myeloma Clinical Trial

Official title:

Quality of Life and Psychological Distress in Patients With Multiple Myeloma and Their Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04388735
• Other study ID #: 19-816
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: May 16, 2022

Study information

• Verified date: May 2020
• Source: Massachusetts General Hospital
• Contact: Elizabeth K O'Donnell, MD
• Phone: 617-643-2517
• Email: ekodonnell[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: May 16, 2022
• Est. primary completion date: November 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Symptoms
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Quality of Life
• Symptom, Behavioral

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Kully Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Quality of life (QOL) Caregiver Description	Describe cargiver QOL scores by associated patient line of therapy	Up to 1 year
Secondary	QOL-Functional Assessment	Describe and compare patient QOL Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) scores by line of therapy. 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	Up to 1 year
Secondary	Patient Burden Assessment-ESAS	Describe and compare patient symptoms (ESAS) scores by line of therapy. The Edmonton Symptom Assessment System (ESAS) will be used to ascertain the symptom burden experienced by patients. This previously validated survey assesses nine symptoms frequently reported by patients with cancer: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath [	Up to 1 year
Secondary	Patient Fatigue Symptoms	Describe and compare patient fatigue symptoms (FACIT-Fatigue) by line of therapy.; The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue), a 13-item FACIT subscale specific to fatigue that measures an individual's level of fatigue during their usual daily activities over the past week.[13, 14] The level of fatigue is measured on a 4-point Likert scale .	Up to 1 year
Secondary	Patient anxiety symptoms	Describe and compare patient anxiety and depression symptoms Hospital Anxiety and Depression Scale (HADS) to assess symptoms of depression and anxiety in all study participants. The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week.. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression	Up to 1 year
Secondary	Patient Depression symptoms	Describe and compare patient anxiety and depression symptoms Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale (HADS) to assess symptoms of depression and anxiety in all study participants. The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week.. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression	Up to 1 year
Secondary	Patient Post-traumatic stress symptoms	Describe and compare post-traumatic stress symptoms (PCL-C) by line of therapy The Post-Traumatic Stress Disorder Checklist (PCL) to assess symptoms of post-traumatic stress in patients and caregivers. The PCL is a 17 item self-reported measure that evaluates symptoms of post traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV	Up to 1 year
Secondary	Patient coping	Describe and compare patient coping (Brief Cope) by line of therapy. The Brief Cope, a 28-item questionnaire that assess 14 methods of coping (e.g., self-distraction, humor, denial) using a 4-point Likert scale	Up to 1 year
Secondary	Caregiver Quality of Life (QOL)	Describe and compare caregiver burden and QOL (CARGOQOL) scores by line of therapy. CareGiver Oncology QOL questionnaire (CARGOQOL) will be used to measure caregiver QOL. The CarGOQOL is a 29-item well-validated instrument to measure QOL in multiple domains.	Up to 1 year
Secondary	Caregiver Burden	Describe and compare caregiver burden and QOL (CARGOQOL) scores by line of therapy. CareGiver Oncology QOL questionnaire (CARGOQOL) will be used to measure caregiver QOL. The CarGOQOL is a 29-item well-validated instrument to measure QOL in multiple domains.	Up to 1 year
Secondary	Caregiver anxiety	Describe and compare caregiver anxiety and depression symptoms (caregiver HADS) by line of therapy. The Hospital Anxiety and Depression Scale will be used to (HADS) to assess symptoms of depression and anxiety in all study participants (patients and family caregivers). The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression	Up to 1 year
Secondary	Caregiver Depression	Describe and compare caregiver anxiety and depression symptoms (caregiver HADS) by line of therapy. The Hospital Anxiety and Depression Scale will be used to (HADS) to assess symptoms of depression and anxiety in all study participants (patients and family caregivers). The HADS is a 14-item questionnaire that contains two 7-item subscales assessing depression and anxiety symptoms during the past week. . Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety or depression	Up to 1 year
Secondary	Caregiver Coping	Describe and compare caregiver coping (Brief Cope) Brief Cope, a 28-item questionnaire that assess 14 methods of coping (e.g., self-distraction, humor, denial) using a 4-point Likert scale	Up to 1 Year