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Individualized Education for Bortezomib-Related Symptom Management in Multiple Myeloma

19. august 2026 oppdatert av: Can Lafci

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

49

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Istanbul
      • İzmir, Istanbul, Tyrkia (Türkiye), 34854
        • Ege University Faculty of Medicine, Berna Türek Chemotherapy Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Individualized Education Group
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.
Atferdsmessig: Individualized 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.
Ingen inngripen: Routine Care Control Group
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Motor Neuropathy Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Sensory Neuropathy Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Abdominal Pain Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Nausea Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Vomiting Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Diarrhea Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Constipation Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Fatigue Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63
Dyspnea Severity Assessed by NCI-CTC Version 2.0
Tidsramme: 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.
Baseline before treatment and education, Day 21, and Day 63

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Can Lafci

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. februar 2018

Primær fullføring (Faktiske)

31. august 2018

Studiet fullført (Faktiske)

31. august 2018

Datoer for studieregistrering

Først innsendt

15. august 2026

Først innsendt som oppfylte QC-kriteriene

15. august 2026

Først lagt ut (Faktiske)

19. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EGE-MASTER_CL_35

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data are not planned to be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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