Multiple MyelomaNCT07774988
Individualized Education for Bortezomib-Related Symptom Management in Multiple Myeloma
A study testing Individualized Nurse-Delivered Education Program in people with Multiple Myeloma, run by Can Lafci at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Individualized Nurse-Delivered Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2018to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine, Berna Türek Chemotherapy Center
İzmir, Istanbul, 34854
About this study
Official title: Investigation of the Effect of Education Given to Patients With Multiple Myeloma on Symptom Severity
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.
- Conditions
- Multiple Myeloma
- Being tested
- Individualized Nurse-Delivered Education Program
- Keywords
- Bortezomib, Patient Education, Symptom Management, Oncology Nursing
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Nurse-Delivered Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Education Group | Experimental | Participants received two individualized, nurse-delivered education sessions in addition to routine care. The education addressed recognition, prevention, and management of common bortezomib-related symptoms. Written and visual educational materials were used, and participants were encouraged to monitor symptoms and contact the researcher when needed. Receives: Behavioral: Individualized Nurse-Delivered Education Program |
| Routine Care Control Group | No intervention | Participants received routine care during the study follow-up period without the individualized education intervention. The education booklet was provided after the final study assessment on day 63. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Neuropathy Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Sensory Neuropathy Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Abdominal Pain Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Nausea Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Vomiting Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Diarrhea Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Constipation Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Fatigue Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Dyspnea Severity Assessed by NCI-CTC Version 2.0
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.
Measured: Baseline before treatment and education, Day 21, and Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start5 Feb 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Lafci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Can Lafci, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774988
- Sponsor's protocol ID
- EGE-MASTER_CL_35
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Education Given to Patients With Multiple Myeloma on Symptom Severity
- ClinicalTrials.gov ID
- NCT07774988
- Acronym / sponsor ID
- EGE-MASTER_CL_35
- Conditions
- Multiple Myeloma
- Keywords
- Bortezomib, Patient Education, Symptom Management, Oncology Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Can LafciUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized Education Group | Experimental | Behavioral: Individualized Nurse-Delivered Education ProgramParticipants received two individualized, nurse-delivered education sessions in addition to routine care. The education addressed recognition, prevention, and management of common bortezomib-related symptoms. Written and visual educational materials were used, and participants were encouraged to monitor symptoms and contact the researcher when needed. |
| Routine Care Control Group | No intervention | –Participants received routine care during the study follow-up period without the individualized education intervention. The education booklet was provided after the final study assessment on day 63. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Nurse-Delivered Education ProgramThe 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. | Behavioural | Individualized Education Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nurse-Delivered Education Program in people with Multiple Myeloma, run by Can Lafci at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Neuropathy Severity Assessed by NCI-CTC Version 2.0 (time frame: Baseline before treatment and education, Day 21, and Day 63). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.