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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Adriana Coletta, MD
- Numero di telefono: 801-213-6012
- Email: adriana.coletta@hci.utah.edu
Backup dei contatti dello studio
- Nome: Rachel Hoobler
- Numero di telefono: 801-646-9800
- Email: rachel.hoobler@hci.utah.edu
Luoghi di studio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- Huntsman Cancer Institute/University of Utah
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Contatto:
- Adriana Coletta, MD
- Email: adriana.coletta@hci.utah.edu
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Contatto:
- Rachel Hoobler
- Email: rachel.hoobler@hci.utah.edu
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Investigatore principale:
- Adriana Coletta, MD
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Intervention Feasibility
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Global Leadership Initiative on Malnutrition (GLIM)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Baseline, Week 9 (End of intervention), Pre-HSCT (Days -14 to -3), Post-HSCT (Days +15 to +28)
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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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Adriana Coletta, MD, Huntsman Cancer Institute
Studiare le date dei record
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Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
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Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
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Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Disturbi della nutrizione
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Neoplasie, plasmacellule
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Malattie nutrizionali e metaboliche
- Malattie emiche e linfatiche
- Malnutrizione
- Mieloma multiplo
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 205119
Informazioni su farmaci e dispositivi, documenti di studio
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