- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01885884
Supportive Care Intervention-Pancreas (SCI-P)
tiistai 10. toukokuuta 2016 päivittänyt: Yael Schenker, MD, MAS, University of Pittsburgh
A Pilot Trial of an Embedded Collaborative Model of Supportive Care for Pancreatic Cancer
This is a pilot, randomized controlled trial of an embedded collaborative model of supportive care designed to improve quality of life and decrease use of unwanted healthcare services at the end of life for patients with advanced pancreatic cancer.
We will enroll 30 patients who are receiving treatment at the Hillman Cancer Center for recently diagnosed, locally advanced or metastatic pancreatic adenocarcinoma, as well as their accompanying caregivers and providers.
Patients will be randomized to receive either the supportive care intervention or usual care.
The purpose of this study is to refine an embedded collaborative model of supportive care and to develop protocols for recruitment, randomization, and longitudinal data collection.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
60
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15232
- University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
Patients:
- Adults (≥ 18 years old)
- Pathologically-confirmed locally advanced or metastatic pancreatic adenocarcinoma diagnosed within the past 8 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 (asymptomatic), 1 (symptomatic but fully ambulatory), or 2 (symptomatic and in bed <50% of the day)
- Planning to receive continued care from an oncologist at the Hillman Cancer Center
- Accompanied by a caregiver (family member or friend) at the first visit
Caregivers:
- Adults (>= 18 years old)
- Family member or friend of an eligible patient
Exclusion Criteria:
Patients:
- Unable to read and respond to questions in English
- Not planning to receive continued care from an oncologist at the Hillman Cancer Center
- Pancreatic neuroendocrine cancer
Caregivers:
- Unable to read and respond to questions in English
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
|
|
Ei väliintuloa: Usual Care
Participants will receive standard oncology care from their oncology providers.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
trial feasibility
Aikaikkuna: up to 2 years
|
We will assess trial feasibility by monitoring number of eligible patients per clinic day, contact rates, interest rates, enrollment rates, randomization rates, intervention visit completion rates, and outcome assessment completion rates.
|
up to 2 years
|
acceptability of intervention participation
Aikaikkuna: 3 months (+/- 3 weeks) from patient enrollment
|
We will report the percentage of patients and caregivers who found the intervention acceptable.
|
3 months (+/- 3 weeks) from patient enrollment
|
intervention fidelity
Aikaikkuna: Up to 2 years
|
We will use post-visit checklists to characterize the number and types of recommended topics covered during each supportive care intervention visit.
|
Up to 2 years
|
perceived effectiveness
Aikaikkuna: 3 months (+/- 3 weeks) from patient enrollment
|
We will report the percentage of patients and caregivers who perceived the intervention to be effective for treating symptoms, understanding their illness, coping, and planning for the future.
|
3 months (+/- 3 weeks) from patient enrollment
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
change in patient quality of life
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in patient quality of life from baseline to 3 months using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep).
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
patient healthcare utilization
Aikaikkuna: up to 2 years
|
We will summarize range and distribution of the following patient healthcare utilization outcomes: number and types of chemotherapy regimens, frequency and timing of chemotherapy regimens, number and length (days) of hospital admissions, number and length (days) of ICU admissions, number of emergency department visits, frequency and timing (days before death) of hospice use, place of death.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
up to 2 years
|
patient quality of life
Aikaikkuna: 3 months (+/- 3 weeks) from patient enrollment
|
We will summarize range and distribution of patient quality of life at 3 months using the FACT-Hep scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) from patient enrollment
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
patient illness understanding and care preferences
Aikaikkuna: 3 months (+/- 3 weeks) from patient enrollment
|
We will assess range and distribution of patient illness understanding using validated questions about patients' perceptions of curability, life expectancy, acknowledgement of whether or not s/he has a terminal illness, and preferences for comfort-oriented vs life-prolonging treatment.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) from patient enrollment
|
change in patient anxiety symptoms
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in patient anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS) administered at baseline and 3 months.
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
change in patient distress
Aikaikkuna: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in patient distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.'
Scores will be compiled to assess range and distribution at 3-months.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
|
change in patient depressive symptoms
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in patient depression from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9).
HADS and PHQ-9 depression scores will be compiled to assess range and distribution at baseline and 3 months.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
change in caregiver distress
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of change in caregiver distress responses from baseline to 3 months, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
change in caregiver burden
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will summarize the range and distribution of the reported change in caregiving burden from baseline to 3 months, collected with the Zarit Burden Interview and Family Member Concerns scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
caregiver grief
Aikaikkuna: 1-3 months after death of enrolled patient
|
We will assess caregiver grief after the death of their loved one (enrolled patient), if the patient dies during study participation and up to 2-year follow up.
We will use the Inventory of Complicated Grief to assess how much and how often caregivers are affected by the loss of their loved one and summarize the range and distribution of this data.
Because this is a pilot study, we will not conduct formal tests of efficacy.
|
1-3 months after death of enrolled patient
|
change in caregiver anxiety symptoms
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in caregiver anxiety symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
change in caregiver depressive symptoms
Aikaikkuna: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
We will assess change in caregiver depressive symptoms from baseline to 3 months with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
|
caregiver perceptions of circumstances surrounding death and preparedness for death
Aikaikkuna: 1-3 months after death of enrolled patient
|
We will assess caregiver perceptions of circumstances surrounding death and preparedness for death using four previously validated questions.
We will summarize range and distribution of responses.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
1-3 months after death of enrolled patient
|
quality of life of seriously ill patients
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient quality of life using the Quality of Life - Seriously Ill Patients (QUAL-E) score.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
patient emotional acceptance of illness
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient emotional acceptance of illness using the PEACE Scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
patient anxiety
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution of patient anxiety using the Hospital Anxiety and Depression Scale (HADS).
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
patient distress
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution in patient distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool, where patients rate their distress on a visual guide from 0, 'no distress' to 10, 'extreme distress.'
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
patient depression
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will assess patient depression from with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9).
HADS and PHQ-9 depression scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
caregiver distress
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will summarize range and distribution in caregiver distress responses, collected with the National Comprehensive Cancer Network (NCCN) Distress Thermometer tool.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
caregiver burden
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will summarize the range and distribution of the reported caregiving burden, collected with the Zarit Burden Interview and Family Member Concerns scale.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
caregiver anxiety symptoms
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will assess caregiver anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
caregiver depressive symptoms
Aikaikkuna: 3 months (+/- 3 weeks) after enrollment
|
We will assess caregiver depressive symptoms with the Hospital Anxiety and Depression Scale (HADS).
HADS scores will be compiled to assess range and distribution.
Because this is a pilot trial, we will not conduct formal tests of efficacy.
|
3 months (+/- 3 weeks) after enrollment
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Yael Schenker, MD, MAS, University of Pittsburgh
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Maanantai 1. heinäkuuta 2013
Ensisijainen valmistuminen (Todellinen)
Lauantai 1. elokuuta 2015
Opintojen valmistuminen (Todellinen)
Lauantai 1. elokuuta 2015
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 7. kesäkuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 24. kesäkuuta 2013
Ensimmäinen Lähetetty (Arvio)
Tiistai 25. kesäkuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Torstai 12. toukokuuta 2016
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 10. toukokuuta 2016
Viimeksi vahvistettu
Sunnuntai 1. toukokuuta 2016
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- PRO13020507
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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