Pretransplant Evaluation by Supportive Care Team for Patients Undergoing HCT for Hematological Malignancies
22. februar 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
7
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Froedtert Hospital and the Medical College of Wisconsin
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Study participation rates
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Completion time for palliative care consultation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Wendy Peltier, MD, Medical College of Wisconsin
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2015
Primær fullføring (Faktiske)
1. oktober 2017
Studiet fullført (Faktiske)
1. oktober 2017
Datoer for studieregistrering
Først innsendt
18. oktober 2014
Først innsendt som oppfylte QC-kriteriene
16. desember 2014
Først lagt ut (Anslag)
22. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. februar 2018
Sist bekreftet
1. februar 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 21301
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