Supportive Care Intervention-Pancreas (SCI-P)
10. mai 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
60
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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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
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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:
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
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Supportive Care Intervention
Monthly (minimum) patient & caregiver visits with a Supportive Care physician, embedded within their standard oncological care (through collaboration with oncology providers).
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Ingen inngripen: Usual Care
Participants will receive standard oncology care from their oncology providers.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
trial feasibility
Tidsramme: 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.
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up to 2 years
|
|
acceptability of intervention participation
Tidsramme: 3 months (+/- 3 weeks) from patient enrollment
|
We will report the percentage of patients and caregivers who found the intervention acceptable.
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3 months (+/- 3 weeks) from patient enrollment
|
|
intervention fidelity
Tidsramme: 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.
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Up to 2 years
|
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perceived effectiveness
Tidsramme: 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.
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3 months (+/- 3 weeks) from patient enrollment
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
change in patient quality of life
Tidsramme: 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
Tidsramme: 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.
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up to 2 years
|
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patient quality of life
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
patient illness understanding and care preferences
Tidsramme: 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.
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3 months (+/- 3 weeks) from patient enrollment
|
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change in patient anxiety symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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1-3 months after death of enrolled patient
|
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quality of life of seriously ill patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Yael Schenker, MD, MAS, University of Pittsburgh
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. juli 2013
Primær fullføring (Faktiske)
1. august 2015
Studiet fullført (Faktiske)
1. august 2015
Datoer for studieregistrering
Først innsendt
7. juni 2013
Først innsendt som oppfylte QC-kriteriene
24. juni 2013
Først lagt ut (Anslag)
25. juni 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO13020507
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