Pretransplant Evaluation by Supportive Care Team for Patients Undergoing HCT for Hematological Malignancies
22 février 2018 mis à jour par: Wendy Peltier, Medical College of Wisconsin
Feasibility of Implementing Pretransplant Evaluation by the Supportive Care Team for Patients Undergoing Hematopoietic Cell Transplantation for Hematological Malignancies
This is a feasibility study of pre-transplant involvement of a palliative care provider in the setting of HCT. Although this is primarily a feasibility pilot, the investigators will explore how patients are affected by the palliative care meetings as well as test data collection mechanisms that would be used in a future randomized clinical trial.
The investigators hypothesis is that patients will be amenable to pre-transplant involvement of the palliative care team and might welcome the chance to discuss palliative care issues separate from the primary team. Palliative care providers also have special training and experience in conducting these interactions and expertise in supportive care practices. They will be available should a patient's condition become life- threatening. This study is therefore designed primarily to evaluate the level of comfort / distress of patients when a palliative care consultation and follow-up are integrated into their care.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
After the patient provides written informed consent, they will be given a survey to collect baseline data.
Because input may be solicited from the caregiver, consent will also be obtained from a caregiver.
Participation is optional for the caregiver and a caregiver is not required for the participant to be in the study.
If the caregiver does not consent to participate in the study, his/her input during meetings will not be documented in the research record.
"Caregiver" may vary from patient to patient, but for the purposes of this study would be an individual who listens to the interview and responds to questions related to the patient's psychosocial history, goals and values.
This information gathered from the caregiver supports the details of the consult but does not stand alone.
The caregiver does not complete an evaluation of the interview but can reach out to study coordinators if the interview causes any distress.The first consultation will be scheduled with a palliative care provider, but will take place after the standard of care meeting with the social worker so that the palliative care clinician can read the social work note and not have to review the same information.
Within one to seven days after the meeting with palliative care, patients will be asked to complete a 15 minute interview to provide feedback on the meeting.
A brief questionnaire will also be administered to the palliative care provider who conducted the consultation, ideally immediately after the meeting.
Patients will meet at least monthly with the palliative care provider while they remain at the transplant center.
Patients will complete additional self-assessments at day 60+/- 7 days and 90+/- 7 days after their transplants.
These surveys may be completed by mail if the patient has been discharged from the center.
The medical records of participants will be reviewed to pilot items collecting data about references to the palliative care consultation and use of ACP within the first 100 days after HCT.
Costs for participants will be retrieved from the inpatient and outpatient accounting systems for the first 100 days after HCT.
Participants may decline to participate in any part of the study or discontinue participation at any time.
Type d'étude
Interventionnel
Inscription (Réel)
7
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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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Froedtert Hospital and the Medical College of Wisconsin
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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:
- Written informed consent
- English as primary language
- Planned allogeneic stem cell transplantation
- At least 18 years of age
Exclusion Criteria:
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team.
- First transplant of a planned tandem procedure (the second transplant is eligible)
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Palliative Care Support
Palliative care meetings will address the following issues: 1) values and meaning of life 2) greatest hopes and fears 3) communication preferences 4) proxy readiness to make decisions, and patient preferences, if the patient were to become seriously ill, and 5) symptom management strategies.
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Palliative care meetings Quality of Life Assessments
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Study participation rates
Délai: 1 year
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The proportion of patients who consent to enroll in the study will be computed based on the number approached.
Reasons for non-participation will be summarized.
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1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Completion time for palliative care consultation
Délai: up to 100 days
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up to 100 days
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Level of comfort / distress attributed to individual parts of the consultation
Délai: Within 1-7 days after the initial consultation
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The post-consultation scores measuring level of comfort or distress per topic in the palliative care consultation will be summarized per item.
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Within 1-7 days after the initial consultation
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Completeness of follow-up data collection
Délai: 1 year after the date last patient is enrolled
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Completeness is defined by the proportion of instrument scores that can be calculated per given time point.
The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients.
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1 year after the date last patient is enrolled
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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: Wendy Peltier, MD, Medical College of Wisconsin
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
1 février 2015
Achèvement primaire (Réel)
1 octobre 2017
Achèvement de l'étude (Réel)
1 octobre 2017
Dates d'inscription aux études
Première soumission
18 octobre 2014
Première soumission répondant aux critères de contrôle qualité
16 décembre 2014
Première publication (Estimation)
22 décembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 février 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 février 2018
Dernière vérification
1 février 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21301
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