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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07932301
Pre-Transplant Nutrition Counseling in Patients With Multiple Myeloma (PREPARE)
PREPARE: PRE-transPlant Nutrition Counseling to Attenuate Malnutrition and Improve REcovery in Patients With Multiple Myeloma
The primary endpoint of this pilot randomized controlled trial (RCT) will evaluate the feasibility and acceptability of an 8-week pre-hematopoietic stem cell transplant (HSCT) nutrition counseling intervention aimed at improving dietary intake and quality before HSCT to attenuate post-HSCT malnutrition among up to 20 patients with multiple myeloma (MM).
Hypothesis: An 8-week pre-transplant nutrition counseling intervention will be feasible and acceptable among patients with MM undergoing HSCT.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Hematopoietic Stem Cell Transplantation (HSCT) is standard of care for multiple myeloma (MM), yet treatment-related toxicities result in post-transplant malnutrition in up to 80% of patients. Conditioning chemotherapy is associated with substantial toxicities, including severe nausea, vomiting, and mucositis, which impair oral intake and disrupt GI function. Peri-transplant malnutrition is associated with increased healthcare utilization, higher infection risk, greater incidence of mucositis, reduced quality of life (QOL), and worse survival.
This pilot, parallel-group randomized controlled trial evaluates the feasibility and acceptability of an 8-week nutrition counseling intervention designed to improve dietary intake and quality among 20 patients with MM undergoing HSCT (1:1 allocation). Counseling begins at the start of induction therapy and continues for 8 weeks through weekly 30-45 minute video sessions delivered by a registered dietitian. The intervention utilizes stepwise, incremental goals targeting energy intake, protein intake, and fruit/vegetable consumption, monitored via a dietary tracking application. Control participants receive usual standard of care, including written educational materials and one pre-HSCT dietitian consultation 2-3 weeks prior to HSCT to discuss anticipated side effects.
PRIMARY OBJECTIVES I. Conduct a pilot randomized controlled trial to evaluate the feasibility and acceptability of an 8-week pre-hematopoietic stem cell transplant (HSCT) nutrition counseling intervention aimed at improving dietary intake and quality before HSCT to attenuate post-HSCT malnutrition among up to 20 patients with multiple myeloma (MM).
EXPLORATORY OBJECTIVES I. Leverage the usual-care control arm to characterize longitudinal changes in protein and energy intake, diet quality, malnutrition risk and status, physical activity, and quality of life from baseline (post-diagnosis, pre-induction therapy) through approximately three weeks post-HSCT to inform refinement of intervention timing, duration, and outcome assessment.
II. Compare the sensitivity and specificity of recommended malnutrition screening tools relative to a validated malnutrition assessment tool to inform selection of the optimal screening tool for patients with multiple myeloma.
III. Estimate the effect of the intervention, compared with usual care, on post-HSCT malnutrition status to inform the design of a larger, adequately powered trial.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Adriana Coletta, MD
- Número de telefone: 801-213-6012
- E-mail: adriana.coletta@hci.utah.edu
Estude backup de contato
- Nome: Rachel Hoobler
- Número de telefone: 801-646-9800
- E-mail: rachel.hoobler@hci.utah.edu
Locais de estudo
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute/University of Utah
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Contato:
- Adriana Coletta, MD
- E-mail: adriana.coletta@hci.utah.edu
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Contato:
- Rachel Hoobler
- E-mail: rachel.hoobler@hci.utah.edu
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Investigador principal:
- Adriana Coletta, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subject age >= 18 years old
- Individuals newly diagnosed with multiple myeloma undergoing hematopoietic stem cell transplantation as part of first line therapy
- Willingness to engage in virtual nutrition counseling intervention one day per week for eight weeks if assigned to the nutrition counseling group
- Willingness to complete 1-3 food records using Cronometer dietary tracking app each week for eight weeks if assigned to the nutrition counseling group
- Willingness to complete four virtual assessment sessions (baseline, post-intervention, pre-HSCT, post-HSCT)
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion Criteria:
- Patients with multiple myeloma for whom hematopoietic stem cell transplantation is not planned
- Patients who do not speak English will be excluded for this pilot trial due to inadequate funds and staffing to successfully execute this trial in languages other than English
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Nutrition Counseling Intervention
8-week pre-HSCT virtual nutrition counseling intervention (1 session per week, 30-45 minutes) delivered by a registered dietitian and completion of 1-3 weekly dietary tracking a dietary tracking application. |
Participants receive one 30-45 minute virtual nutrition counseling session per week for 8 weeks starting on or within 7 days after Cycle 1 Day 1 of induction therapy. Sessions are delivered by a registered dietitian using the Nutrition Care Process framework with stepwise goal setting targeting energy, protein, and fruit/vegetable intake based on food records tracked via a dietary tracking application. |
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Comparador Ativo: Usual Care
Standard clinical care including AICR educational booklet provided on Cycle 1 Day 1 of induction therapy and standard pre-HSCT dietitian consultation 2-3 weeks prior to transplant. |
Participants receive standard medical care, including the American Institute for Cancer Research (AICR) Living with Cancer handbook on Cycle 1 Day 1 of induction therapy and a standard dietitian consultation 2-3 weeks prior to HSCT regarding expected treatment side effects. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intervention Feasibility
Prazo: End of 8-week intervention (Week 9)
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Feasibility is defined as: (1) >=40% enrollment rate among potentially eligible patients, (2) >=70% completion of the 8-week intervention, and (3) >=70% attendance of >=75% of scheduled counseling sessions (>=6 sessions) and completion of >=1 food record per week. |
End of 8-week intervention (Week 9)
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Intervention Acceptability
Prazo: End of 8-week intervention (Week 9)
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Acceptability assessed using an end-of-intervention survey completed by intervention participants. Considered acceptable if >=80% of all agreement-based responses are "Agree" or "Strongly agree". |
End of 8-week intervention (Week 9)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Global Leadership Initiative on Malnutrition (GLIM)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)]
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Malnutrition status will be assessed according to the GLIM criteria. A malnutrition diagnosis requires at least one etiologic criterion (reduced food intake or assimilation and/or disease burden or inflammation) and at least one phenotypic criterion (weight loss, low body mass index, and/or reduced muscle mass) are present. Severity is graded as moderate or severe based on the phenotypic criteria. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)]
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Malnutrition Screening Tool (MST)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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The Malnutrition Screening Tool (MST) is a two-question screening tool that assesses malnutrition risk. Scores range from 0-5. Scores >=2 indicate malnutrition risk, whereas scores <2 indicate no risk. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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NUTRISCORE
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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NUTRISCORE includes the MST questions and additional items related to cancer site and anticancer treatment. Scores range from 0 to 11; scores ≥5 indicate malnutrition risk, whereas scores <5 indicate no malnutrition risk. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Malnutrition Universal Screening Tool (MUST)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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The MUST assesses BMI, unintentional weight loss, and the acute disease effect. Scores range from 0 to 6. A score of 0 indicates low risk of malnutrition, 1 indicates medium risk, and scores ≥2 indicate high risk of malnutrition. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Mini Nutritional Assessment-Short Form (MNA-SF)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
|
The MNA-SF is a six-item screening tool used to assess nutritional status in older adults. Scores range from 0 to 14; scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnutrition. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Nutrition Risk Screening 2002 (NRS-2002)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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The NRS-2002 assesses impaired nutritional status, disease severity, and age. Scores range from 0 to 7; scores ≥3 indicate nutritional risk, whereas scores <3 indicate no nutritional risk. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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The PG-SGA SF is a four-item, patient-completed nutrition screening tool assessing weight history, food intake, nutrition impact symptoms, and activity and function. Scores range from 0-36. A score ≥7 indicates malnutrition risk. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Protein intake
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Average daily protein intake, measured in grams per day, will be calculated from 1-3-day food records collected using a dietary tracking application. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Energy intake
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Average daily energy intake, measured in kilocalories per day, will be calculated from 1-3-day food records collected using a dietary tracking application. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Godin Leisure-Time Exercise Questionnaire.
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. The Leisure Score Index is calculated by weighting the weekly frequency of strenuous, moderate, and mild activity by 9, 5, and 3 metabolic equivalents, respectively, and summing the weighted values. Scores have no fixed upper limit; higher scores indicate greater leisure-time physical activity. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Mini Eating Assessment Tool (mini-EAT)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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The Mini-EAT is a nine-item dietary screener that assesses diet quality. Scores range from 0 to 100, with lower scores indicating poorer diet quality and higher scores indicating better diet quality. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Prazo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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The EORTC QLQ-C30 is a 30-item questionnaire that assesses global health status/QOL, physical, role, emotional, cognitive, and social functioning, and cancer-related symptoms. All scale scores range from 0 to 100. Higher global health status/QOL and functioning scores indicate better QOL and functioning, whereas higher symptom scores indicate greater symptom burden. |
Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adriana Coletta, MD, Huntsman Cancer Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Distúrbios Nutricionais
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Doenças Nutricionais e Metabólicas
- Doenças hemic e linfáticas
- Desnutrição
- Mieloma múltiplo
Outros números de identificação do estudo
- 205119
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