Multiple MyelomaNCT04388735
Multiple Myeloma (MM) Quality of Life (QOL) Study
An observational study of Multiple Myeloma and Quality of Life, run by Massachusetts General Hospital at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Quality of Life, Symptom, Behavioral
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2020to 16 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients receiving therapy for Multiple Myeloma and their identified/designated caregivers.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Elizabeth K O'Donnell, MD, 617-643-2517, ekodonnell@mgh.harvard.edu
Elizabeth K O'Donnell, MD
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Jacalyn Rosenblatt, MD, 617-667-9920, jrosenb1@bidmc.harvard.edu
Jacalyn Rosenblatt, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Omar Nadeem, MD, 617-658-6000, Omar_Nadeem@DFCI.HARVARD.EDU
Omar Nadeem, MD
About this study
Official title: Quality of Life and Psychological Distress in Patients With Multiple Myeloma and Their Caregivers
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.
Read the 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
- Being tested
- Questionnaire
- Keywords
- Multiple Myeloma, Quality of Life, Symptom, Behavioral
- Medical subject headings
- Multiple Myeloma, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaire | |
| 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 Receives: Behavioral: Questionnaire | |
| 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 Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Up to 1 year
Quality of life (QOL) Caregiver Description
Describe cargiver QOL scores by associated patient line of therapy
Measured: Up to 1 year
Secondary outcomes (12)
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
Measured: Up to 1 year
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 [
Measured: Up to 1 year
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 .
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 year
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
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study startJun 2020 (estimated)
- Primary completion15 Nov 2021 (estimated)
- Study completion16 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kully Family Foundation
- Responsible party
- Principal investigator, Elizabeth O'Donnell, Massachusetts General Hospital
- Investigators
- Elizabeth K O'Donnell, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388735
- Sponsor's protocol ID
- 19-816
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Psychological Distress in Patients With Multiple Myeloma and Their Caregivers
- ClinicalTrials.gov ID
- NCT04388735
- Acronym / sponsor ID
- 19-816
- Conditions
- Multiple Myeloma, Quality of Life, Symptom, Behavioral
- Keywords
- Multiple Myeloma, Quality of Life, Symptom, Behavioral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Kully Family Foundation
- Study start
- Jun 2020 (estimated)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 16 May 2022 (estimated)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed MM 1st Line and Caregivers | – | Behavioral: QuestionnaireThis 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 | – | Behavioral: QuestionnaireThis 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 | – | Behavioral: QuestionnaireThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients receiving therapy for Multiple Myeloma and their identified/designated caregivers.
Key inclusion criteria (7 listed)
- Adult patients (greater than 18 years) receiving active therapy for MM.
- Ability to read questions in English or willing to complete questionnaires with the assistance of an interpreter.
- 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
Key exclusion criteria (3 listed)
- Patient Exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireSeries of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely. | Behavioural | MM patients receiving ≥ 4 lines of therapy and Cargivers, MM receiving 1-3 prior lines of therapy and Caregivers, Newly Diagnosed MM 1st Line and Caregivers |
Primary outcome
Quality of life (QOL) Patient Description
Time frame: Up to 1 year
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].
Quality of life (QOL) Caregiver Description
Time frame: Up to 1 year
Describe cargiver QOL scores by associated patient line of therapy
12 secondary outcomes
QOL-Functional Assessment
Time frame: Up to 1 year
Patient Burden Assessment-ESAS
Time frame: Up to 1 year
Patient Fatigue Symptoms
Time frame: Up to 1 year
Patient anxiety symptoms
Time frame: Up to 1 year
Patient Depression symptoms
Time frame: Up to 1 year
Patient Post-traumatic stress symptoms
Time frame: Up to 1 year
Patient coping
Time frame: Up to 1 year
Caregiver Quality of Life (QOL)
Time frame: Up to 1 year
Caregiver Burden
Time frame: Up to 1 year
Caregiver anxiety
Time frame: Up to 1 year
Caregiver Depression
Time frame: Up to 1 year
Caregiver Coping
Time frame: Up to 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K O'Donnell, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Quality of Life, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth K O'Donnell, MD (617-643-2517, ekodonnell@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (QOL) Patient Description (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.