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- Essai clinique NCT03106090
Studying Survivorship Care Plans in Head and Neck Cancer
14 janvier 2020 mis à jour par: Duke University
Comparison of Enhanced Survivorship Care Plans in a Head and Neck Cancer Clinic to Standard of Care
The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics.
Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria.
These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment.
Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences.
The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
6
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke Health, Duke Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Completed treatment for a head or neck cancer at Duke Cancer Center within 4 months of consent OR
- Will complete treatment for a head and neck cancer at Duke Cancer Center within 3 weeks of consent AND
- Able to read and understand English
- Capable of giving informed consent
- Are at least age 18.
Exclusion Criteria:
- incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: No SCP Control
Patients returning for early follow-up who did not receive SCP.
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Aucune intervention: SOC SCP Control
Patients returning for early follow-up who received a standard of care SCP.
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Expérimental: eSCP Intervention
Patients currently receiving treatment who will be enrolled to receive an "enhanced" SCP (eSCP) with additional information beyond ASCO guidelines tailored to patient concerns and preferences.
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The eSCP includes a treatment summary section, a section detailing follow-up and test recommendations, a section on anticipated and potential side effects, as well as additional information specific to their experience/concerns.
They will receive a patient education notebook outlining symptoms and their management that is tailored to those that the subject may be likely to experience during their survivorship care trajectory.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Head and Neck Cancer Survivor Knowledge
Délai: 5 minutes to complete 3 months after treatment end
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Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale
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5 minutes to complete 3 months after treatment end
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Change in Head and Neck Cancer Survivor Knowledge
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale in intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Distress in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist
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5 minutes to complete 3 months after treatment end
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Distress in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Assesses distress through the use of the NCCN Distress Thermometer
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5 minutes to complete 3 months after treatment end
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Change in distress for head and neck cancer survivors
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Change in distress for head and neck cancer survivors
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses distress through the use of the NCCN Distress Thermometer in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Uncertainty in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form
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5 minutes to complete 3 months after treatment end
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Change in uncertainty in head and neck cancer survivors
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Quality of life in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35)
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5 minutes to complete 3 months after treatment end
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Change in quality of life in head and neck cancer survivors
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35) in the intervention group
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Self-efficacy in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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5 minutes to complete 3 months after treatment end
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Change in self-efficacy in head and neck cancer survivors
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Information processing in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Assesses information processing in cancer patients through the use of the EORTC QLQ Information Module (QLQ INFO25)
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5 minutes to complete 3 months after treatment end
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Change in information processing in head and neck cancer survivors
Délai: 5 minutes to complete; measured pre-intervention and 3 months after intervention
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Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
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5 minutes to complete; measured pre-intervention and 3 months after intervention
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Survivorship care plan perceptions in head and neck cancer survivors
Délai: 5 minutes to complete 3 months after treatment end
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Using open ended questions during a qualitative interview, survivors will provide their perception of how survivorship care plans were useful or not in their care
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5 minutes to complete 3 months after treatment end
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Survivorship needs after treatment completion -- primary care provider documentation
Délai: 10 minutes to complete documentation review of 6 months of PCP records
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Using a documentation checklist developed by the study team, discussions on survivorship needs when returning to clinic will be assessed with a focus on symptom management or incorporation of healthy behaviors to reduce cancer recurrence
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10 minutes to complete documentation review of 6 months of PCP records
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Deborah H Allen, PhD, RN, Duke Health
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
19 avril 2017
Achèvement primaire (Réel)
2 janvier 2020
Achèvement de l'étude (Réel)
2 janvier 2020
Dates d'inscription aux études
Première soumission
29 mars 2017
Première soumission répondant aux critères de contrôle qualité
4 avril 2017
Première publication (Réel)
10 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 janvier 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 janvier 2020
Dernière vérification
1 janvier 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00079937
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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