- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04552912
Physical Activity to Improve Patient Reported Outcomes for Adults With Acute Leukemia (Build Stamina)
Testing a Nurse-Led Evidence-Based Exercise Program to Improve Patient-Reported Outcomes in Adults With Acute Leukemia
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Rationale/Significance of Study: Acute leukemias (AL) are an aggressive and often debilitating cancer with increasing incidence among those with a prior history of cancer and older adults. Initial treatment is complex and even when remission is initially achieved, there is a high risk for disease relapse. Research shows that individual characteristics such as decreased physical function are associated with poor survival in AL. Intensive chemotherapy remains the standard treatment necessary for survival. Chemotherapy administration entails extended hospitalization for treatment and to monitor and manage multiple symptoms, life-threatening complications, and other adverse events which often necessitate intensive care unit admissions. Given the significance of this illness and its complications, adults with AL are commonly encouraged to rest during induction treatment. Unfortunately, the long periods of hospitalization and rest result in diminished physical function during and after treatment. In fact, patients are unable to function at pre-cancer levels which can delay or prevent future intensive treatments, such as hematopoietic stem cell transplant, that are most likely to be life-saving. Currently there are no clinical interventions specific to assisting adults recovering from intense induction treatment. However, PA programs have been shown to improve physical function and reduce symptoms in many other clinical/disease contexts. Specifically, the Otago home-based program, has undergone extensive testing internationally and has demonstrated effectiveness for improving strength, mobility, balance and preventing falls in vulnerable older adults. Efforts to assess the clinical efficacy of evidence-based PA programs for adults recovering from induction treatment for AL are critically needed.
Conceptual/Theoretical Framework: The evaluation approach for this study is guided by the RE-AIM (reach, efficacy, adoption, implementation, maintenance) evaluation framework. The tailored PA intervention is guided by the information-motivation-behavioral (IMB) change theory.
Main Research Variable(s): Reach: percent of eligible patients enrolled; Efficacy: physical function assessments; Adoption: qualitative interviews to understand what is needed to adopt the intervention into practice; Implementation: intervention fidelity/adherence; Maintenance: qualitative interviews to understand what is needed to sustain the intervention in practice.
Design: This is a two-group randomized controlled trial (RCT) with an implementation-related process evaluation of the tailored PA intervention. Participants will be randomized to either the nurse-led PA intervention or the attention-control group.
Setting: NCI designated Comprehensive Cancer Center Sample: Adults diagnosed with AL receiving consolidation/maintenance chemotherapy Methods: A longitudinal RCT over 3-months to evaluate the efficacy of our nurse-led tailored home-based PA program versus attention-control. Participants will complete physical function tests and questionnaires at baseline, 6-weeks and 3-months. Both quantitative and qualitative data will be collected for summative and formative data relevant to the reach, adoption, implementation, and maintenance domains of RE-AIM.
Implications for Practice: Adults with AL experience decreased physical function and concurrent symptoms that negatively affects quality of life (QOL) and may increase their risk for further adverse events. This intervention would provide oncology nurses with tools to support patients to engage in behaviors that improve their QOL.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514
- University of North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Health System
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- >18 years
- Diagnosed with either acute leukemia
- Receiving either maintenance or consolidation chemotherapy
- Able to walk independently for 4 meters with or without gait aid.
Exclusion Criteria:
- non-English speaking
- receiving induction chemotherapy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Build Stamina Group
The Build StaMINA (Biobehavioral Self-Management INtervention using physical Activity) is a tailored evidence-based physical activity (PA) program designed to improve endurance, strength, and balance which are all areas of physical function, that adults with acute leukemia (AL) post-induction are known to have diminished capacity.
The Build StaMINA program will be tailored to their current Physical Function, per assessment.
The detailed PA prescription includes each exercise in the program as well as the frequency, number of repetitions each day and rate of perceived exertion (RPE) for each exercise.
The repetitions and RPE are based on the participants' current Physical Function Assessment and will be assigned based on our evidence-based algorithm.
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Build StaMINA intervention is a self-management intervention that provides information, motivation, behavioral skills to engage in PA, and ultimately a tailored PA program for adults with AL who are receiving consolidation/maintenance chemotherapy.
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Aucune intervention: Attention-Control Group
Participants assigned to the attention control group will have a Physical Function Assessment at baseline after informed consent has been provided and prior to randomization.
Participants will also be asked to complete questionnaires regarding at baseline, 6-weeks and 3 months.
Those in the attention-control group will also receive a newsletter detailing the benefits of participating in regular PA as well as regular phone calls by study team to discuss general health and wellbeing at the same schedule as intervention group.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Physical Function- Short Physical Performance Battery Protocol
Délai: 12-weeks
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Measured via evaluation on Chair Stand Test (up to 4 points), Gait Speed Test (up to 4 points) and the 4 Test Balance Scale (up to 4 points) scores can range from 0-12 points.
Higher scores = better physical function
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12-weeks
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Physical Function- 6 Minute walk test
Délai: 12-weeks
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The 6 minute walk Test measures an individuals ability to walk in meters for 6 minutes.
The distance walk in meters is recorded.
Higher meter = better physical function
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12-weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient-Reported Outcomes- Cognition
Délai: 12-weeks
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Measured via the Montreal Cognitive Assessment.
Scores range from 0-30 with higher scores = better cognition
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12-weeks
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Patient-Reported Outcomes-Fatigue
Délai: 12-weeks
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Measured via Patient-Reported Outcomes Measurement Information System-Patient-Reported Outcomes Measurement Information System-Fatigue 8. Scores range from 8-40 with higher scores = worse fatigue
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12-weeks
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Patient-Reported Outcomes-Disturbed Sleep
Délai: 12-weeks
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Measured via Patient-Reported Outcomes Measurement Information System- Patient-Reported Outcomes Measurement Information SystemDisturbed Sleep 8b.
Scores range from 8-40 with higher scores = worse disturbed sleep
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12-weeks
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Patient-Reported Outcomes-Anxiety
Délai: 12-weeks
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Measured via Patient-Reported Outcomes Measurement Information System-Patient-Reported Outcomes Measurement Information System-Anxiety-8.
Scores range from 8-40 with higher scores = worse anxiety
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12-weeks
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Patient-Reported Outcomes-Depression
Délai: 12-weeks
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Measured via Patient-Reported Outcomes Measurement Information System- Depression-8.
Scores range from 8-40 with higher scores = worse depression
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12-weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Tara A Albrecht, PhD, ACNP-BC, ACNP-BC, ACHPN, Duke University School of Nursing
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00106590
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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