Skip to main content
OpenTrials
Completed

NCT Number: NCT04248244

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Care

Other

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.

FACT-MM questionnaire

Other

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.

HADS questionnaire

Other

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.

Primary outcomes

  1. Self-reported QOL as measured by FACT-MM scores

    Time frame: At baseline

    Self-reported QOL as measured by FACT-MM scores

    The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

    FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

    Higher scores mean better QOL for all sections and total scores.

  2. Self-reported QOL as measured by FACT-MM scores

    Time frame: 3 months

    Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

    FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

    Higher scores mean better QOL for all sections and total scores.

  3. Self-reported QOL as measured by FACT-MM scores

    Time frame: 6 months

    Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

    FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

    Higher scores mean better QOL for all sections and total scores.

  4. Self-reported QOL as measured by FACT-MM scores

    Time frame: 9 months

    Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

    FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

    Higher scores mean better QOL for all sections and total scores.

  5. Self-reported QOL as measured by FACT-MM scores

    Time frame: 12 months

    Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

    FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

    Higher scores mean better QOL for all sections and total scores.

  6. Change in QOL relative to baseline as measured by FACT-MM scores

    Time frame: 3 months, 6 months, 9 months and 12 months

    Change in QOL relative to baseline as measured by FACT-MM scores.

    The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

    FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

    Higher scores mean better QOL for all sections and total scores.

  7. Number of participants with self-reported symptoms of depression and anxiety

    Time frame: At baseline

    Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).

  8. Number of participants with self-reported symptoms of depression and anxiety

    Time frame: 3 months

    Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).

  9. Number of participants with self-reported symptoms of depression and anxiety

    Time frame: 6 months

    Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).

  10. Number of participants with self-reported symptoms of depression and anxiety

    Time frame: 9 months

    Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).

  11. Number of participants with self-reported symptoms of depression and anxiety

    Time frame: 12 months

    Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).

  12. Number of PC visits made in the first 12 months after diagnosis

    Time frame: At 12 months

    Feasibility of monthly PC visits as measured by the number of PC visits made in the first 12 months after diagnosis

  13. Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions

    Time frame: At 12 months

    Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2020
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.