Testing Early Palliative Care for multiple myeloma in relapse
Official title: Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
Early Palliative Care
see previous description
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +(i) Age ≥18 years; (ii) A new diagnosis of multiple myeloma or at progression of disease necessitating a change in treatment plan, or relapsed/refractory aggressive B cell lymphoma after one prior line of therapy; (iii) Eastern Cooperative Oncology Group (ECOG) performance status 0-3; (iv) Willingness to complete symptom screeningScreeningThe checks done before joining, to see whether a study fits.Read more →; and (v) At least one ESAS-r-plus symptom scored at ≥3 at time of recruitment.
Exclusion
- −(i) Age ≥18 years; (ii) Caregiver of a patient with relapsed B cell lymphoma; and (iii) Willing to attend at least 1 PCC visit with the patient.
- −(i) Insufficient English literacy to complete study procedures; (ii) Hematologist-determined poor cognitive status; (iii) Current palliative care team involvement at PM or elsewhere; and (iv) Not receiving ongoing follow upFollow-upContinued check-ins after the treatment part is finished.Read more → with malignant hematology team at PM.
- −Caregiver eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more →:
- −Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −(i) Insufficient verbal and/or written English literacy to complete study procedures; or (ii) Patient not participating in study.
- −Healthcare provider eligibility criteria:
- −Inclusion criteria:
- −(i) Specialized staff physician, fellow, clinical nurse specialist, or clinic nurse from the outpatient malignant hematology team or palliative care team at PM working clinically with patients with multiple myeloma; and (ii) Working in their clinical area for at least 12 months.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Early Palliative Care.
Registry label: A: Early Palliative Care
Group B receives no study treatment and is followed for comparison.
Registry label: B: Usual Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 144 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only) — measured over 12 months.
Patient quality of life as measured by the FACIT-Pal — measured over 3 months after enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06485076 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Early Palliative CareOther
see previous description
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 12 months.
The study as a whole is currently expected to finish around 2027-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 144 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life. Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden, mood, and quality of life in patients with solid tumours (e.g. lung, breast or gynecological cancers), but has not been explored among patients with blood cancers to date. The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) attending the Princess Margaret Cancer Centre. The main goals of the study are: * To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only) * To see if this early palliative care intervention works well for these patients and caregivers * To compare patient and caregiver experiences with early palliative care and usual care * To explore perceptions and experiences of providing palliative care among healthcare providers involved in the care of these patients and caregivers. Patients, and their respective caregivers if participating, will be randomly assigned to one of two groups: one group will receive early palliative care in addition to usual care from their blood cancer doctor, and the other group will receive usual care from their blood cancer doctor only. All participants will be asked to fill out questionnaires about their quality of life, symptom burden, mood, and satisfaction with care throughout the study. Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care and their caregivers. Some patients and caregivers will be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study. Some healthcare providers who care for these patients will also be asked to take part in interviews at the end of the trial to describe their perceptions and experiences of providing palliative care. The researchers will use the results of this study to guide in the development of a larger clinical trial.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.