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Completed

NCT Number: NCT07774988

Individualized Education for Bortezomib-Related Symptom Management in Multiple Myeloma

This study evaluated an individualized, nurse-delivered education program for managing treatment-related symptoms in patients with newly diagnosed multiple myeloma receiving bortezomib for the first time. A total of 40 patients participated. Twenty patients received two individual education sessions in addition to routine care, while 20 patients in the control group received routine care. The education focused on recognition, prevention, and management of common bortezomib-related symptoms, including peripheral neuropathy, pain, nausea, vomiting, diarrhea, constipation, fatigue, anemia, bleeding risk, infection risk, and dyspnea. Treatment-related symptoms were assessed before treatment and education (baseline), on day 21, and on day 63. The study aimed to evaluate whether individualized patient education was associated with differences in the occurrence and severity of treatment-related symptoms over time.

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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

Ege University Faculty of Medicine, Berna Türek Chemotherapy Center

İzmir, Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older Newly diagnosed with multiple myeloma Scheduled to receive bortezomib 1.3 mg/m² on days 1, 4, 8, and 11 No disease or condition that could affect the nervous system, such as brain metastasis or diabetes Able to communicate Able to read and write Willing to participate in the study No cognitive impairment

Exclusion criteria

  • Younger than 18 years Unstable vital signs History of alcohol use Communication impairment Unwilling to participate in the study

Treatment and study plan

Individualized Nurse-Delivered Education Program

Behavioral

The intervention consisted of two individualized education sessions delivered by the researcher using a Care and Treatment Guide for Patients and Families. The program addressed multiple myeloma and management of bortezomib-related peripheral neuropathy, pain, nausea, vomiting, diarrhea, constipation, fatigue, anemia, bleeding risk, infection risk, and dyspnea. Written and visual materials were used. The second session reinforced topics that were not fully understood, encouraged symptom monitoring with a diary, and provided telephone access to the researcher.

Primary outcomes

  1. Motor Neuropathy Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Motor neuropathy severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 motor neuropathy grading scale. Severity was graded from 0 to 4, with 0 indicating no motor neuropathy and higher grades indicating greater severity; grade 4 indicates paralysis.

  2. Sensory Neuropathy Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Sensory neuropathy severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 sensory neuropathy grading scale. Severity was graded from 0 to 4, with 0 indicating no sensory neuropathy and higher grades indicating greater symptom severity.

  3. Abdominal Pain Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Abdominal pain severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 abdominal pain grading scale. Severity was graded from 0 to 4, with 0 indicating no abdominal pain and higher grades indicating greater severity; grade 4 indicates life-threatening severity.

  4. Nausea Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Nausea severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 nausea grading scale. Severity was graded from 0 to 3, with 0 indicating no nausea and higher grades indicating greater symptom severity.

  5. Vomiting Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Vomiting severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 vomiting grading scale. Severity was graded from 0 to 4, with 0 indicating no vomiting and higher grades indicating greater symptom severity; grade 4 indicates life-threatening severity.

  6. Diarrhea Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Diarrhea severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 diarrhea grading scale. Severity was graded from 0 to 4, with 0 indicating no diarrhea and higher grades indicating greater symptom severity.

  7. Constipation Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Constipation severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 constipation grading scale. Severity was graded from 0 to 4, with 0 indicating no constipation and higher grades indicating greater symptom severity; grade 4 indicates obstruction or toxic megacolon.

  8. Fatigue Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Fatigue severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 fatigue grading scale. Severity was graded from 0 to 4, with 0 indicating no fatigue and higher grades indicating greater symptom severity.

  9. Dyspnea Severity Assessed by NCI-CTC Version 2.0

    Time frame: Baseline before treatment and education, Day 21, and Day 63

    Dyspnea severity was assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 dyspnea grading scale. Severity was graded from 0 to 4, with 0 indicating no dyspnea and higher grades indicating greater symptom severity; grade 4 indicates dyspnea at rest or a need for ventilatory support.

Sponsors and collaborators

Lead sponsor

Can Lafci

Other

Registry information

Official study title

Investigation of the Effect of Education Given to Patients With Multiple Myeloma on Symptom Severity

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

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.

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