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Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Multiple Myeloma

Treatments

Other: HADS questionnaire
Other: FACT-MM questionnaire
Other: Palliative Care

Study type

Interventional

Funder types

Other

Identifiers

NCT04248244
CASE2A19

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Early Palliative Care Integration
Experimental group
Description:
12 months of PC with concurrent standard treatment for MM, QOL assessments
Treatment:
Other: Palliative Care
Other: FACT-MM questionnaire
Other: HADS questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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