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

NCT04248244 | Completed

• 1 other identifier: CASE2A19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (13)

• Self-reported QOL as measured by FACT-MM scores

  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.

  At baseline

• Self-reported QOL as measured by FACT-MM scores

  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 months

• Self-reported QOL as measured by FACT-MM scores

  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 months

• Self-reported QOL as measured by FACT-MM scores

  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.

  9 months

• Self-reported QOL as measured by FACT-MM scores

  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.

  12 months

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

  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.

  3 months, 6 months, 9 months and 12 months

• Number of participants with self-reported symptoms of depression and anxiety

  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).

  At baseline

• Number of participants with self-reported symptoms of depression and anxiety

  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).

  3 months

• Number of participants with self-reported symptoms of depression and anxiety

  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).

  6 months

• Number of participants with self-reported symptoms of depression and anxiety

  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 months

• Number of participants with self-reported symptoms of depression and anxiety

  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 months

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

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

  At 12 months

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

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

  At 12 months

Study Arms (1)

Early Palliative Care Integration

EXPERIMENTAL

12 months of PC with concurrent standard treatment for MM, QOL assessments

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

Interventions

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.

Early Palliative Care Integration

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.

Early Palliative Care Integration

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.

Early Palliative Care Integration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Samala RV, Nurse DP, Chen X, Wei W, Crook JJ, Fada SD, Valent J. Effects of early palliative care integration on patients with newly diagnosed multiple myeloma. Support Care Cancer. 2024 Jun 27;32(7):468. doi: 10.1007/s00520-024-08665-2.

  PMID: 38937310 DERIVED

Related Links

• Publication link

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Palliative Care; 4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Renato Samala, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: February 17, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)