NCT04248244

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

A Pilot Study to Determine the Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	Palliative Care	Early PC Integration - Participants 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. Participants will be scheduled to meet with a PC provider at least once per month. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers. All participants will receive routine oncologic care throughout the study period.
OTHER	FACT-MM questionnaire	FACT-MM questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.
OTHER	HADS questionnaire	HADS questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.

Timeline

• Start date: 2020-02-17
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2020-01-30
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States