Clinical trial NCT04248244: Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
Official title: A Pilot Study to Determine the Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multiple Myeloma (MM) is a common type of cancer involving the cells in the blood (commonly affecting bones, kidneys and blood). Although it remains incurable, MM has become a highly treatable form cancer thanks to new and improved treatment modalities. As patients deal with this disease, they often suffer from multiple symptoms that are caused by both the disease itself and the different drugs used to treat it. Research has shown that the most common symptoms patients suffer from include pain, constipation, tiredness, tingling in hands and feet, breathlessness, sadness and difficulty remembering things. These symptoms may negatively affect the quality of life of patients.

Palliative care (PC) is a type of treatment aimed at relieving symptoms and promoting the most optimal quality of life (QOL) for patients and their caregivers. Research has shown that patients with certain types of cancers, such as colon cancer and lung cancer, do better if they are seen by a PC provider early in the course of their disease. This study seeks to determine the effects of early PC involvement on participants with newly diagnosed MM

Detailed description: This is a pilot study with a prospective cohort design, and based in the outpatient or ambulatory care setting. Each participant will be followed for 12 months.

Twenty eligible patients will be enrolled, and within eight weeks of diagnosis. Patients will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers and participants will receive routine oncologic care throughout the study period.

The primary objective of this study is to obtain preliminary data on the effects of early PC involvement in a cohort of patients with newly diagnosed symptomatic MM

The secondary objectives of this study are to assess self-reported QOL, estimate the change in QOL relative to baseline, estimate number of participants with self-reported symptoms of depression and anxiety, to determine if monthly PC visits are feasible for participants, and to estimate health services utilization.

Eligibility criteria: Inclusion Criteria:

* Must be within eight weeks of being diagnosed with symptomatic MM based on current diagnostic criteria
* Able to read and respond to questions in English
* Have an ECOG performance status of 0, 1, 2 or 3
* Receiving oncologic care at a Cleveland Clinic facility

Exclusion Criteria:

* Have seen a PC provider in any setting (i.e., inpatient, outpatient or home-based)
* Need immediate referral to PC for hospice transition

Primary outcomes:
measure: Self-reported QOL as measured by FACT-MM scores
timeFrame: At baseline
measure: Self-reported QOL as measured by FACT-MM scores
timeFrame: 3 months
measure: Self-reported QOL as measured by FACT-MM scores
timeFrame: 6 months
measure: Self-reported QOL as measured by FACT-MM scores
timeFrame: 9 months
measure: Self-reported QOL as measured by FACT-MM scores
timeFrame: 12 months
measure: Change in QOL relative to baseline as measured by FACT-MM scores
timeFrame: 3 months, 6 months, 9 months and 12 months
measure: Number of participants with self-reported symptoms of depression and anxiety
timeFrame: At baseline
measure: Number of participants with self-reported symptoms of depression and anxiety
timeFrame: 3 months
measure: Number of participants with self-reported symptoms of depression and anxiety
timeFrame: 6 months
measure: Number of participants with self-reported symptoms of depression and anxiety
timeFrame: 9 months
measure: Number of participants with self-reported symptoms of depression and anxiety
timeFrame: 12 months
measure: Number of PC visits made in the first 12 months after diagnosis
timeFrame: At 12 months
measure: Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions
timeFrame: At 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Renato Samala, MD
role: PRINCIPAL_INVESTIGATOR
References: