Multiple Myeloma
Conditions
Keywords
Bortezomib, Patient Education, Symptom Management, Oncology Nursing
Brief summary
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.
Interventions
BEHAVIORALIndividualized Nurse-Delivered Education Program
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.
Sponsors
Can Lafci
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants were assigned to two parallel groups. The education group received individualized, nurse-delivered education in addition to routine care, whereas the control group received routine care. Initial group assignment was made by coin toss; thereafter, age- and sex-matched control participants were enrolled sequentially. Because this procedure did not constitute full randomization, the study was classified as quasi-experimental with a matched control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Able to communicate * Able to read and write * Willing to participate in the study
Exclusion criteria
* Younger than 18 years * Presence of a disease or condition that could affect the nervous system, such as brain metastasis or diabetes * Cognitive impairment * Unstable vital signs * History of alcohol use * Communication impairment * Unwilling to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Neuropathy Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Sensory Neuropathy Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Abdominal Pain Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Nausea Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Vomiting Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Diarrhea Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Constipation Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Fatigue Severity Assessed by NCI-CTC Version 2.0 | 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. |
| Dyspnea Severity Assessed by NCI-CTC Version 2.0 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed