Supportive Care Intervention-Pancreas (SCI-P)
10 mei 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- University of Pittsburgh Cancer Institute (UPCI), Hillman Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Geen tussenkomst: Usual Care
Participants will receive standard oncology care from their oncology providers.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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trial feasibility
Tijdsspanne: up to 2 years
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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
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acceptability of intervention participation
Tijdsspanne: 3 months (+/- 3 weeks) from patient enrollment
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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
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intervention fidelity
Tijdsspanne: Up to 2 years
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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
Tijdsspanne: 3 months (+/- 3 weeks) from patient enrollment
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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change in patient quality of life
Tijdsspanne: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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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.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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patient healthcare utilization
Tijdsspanne: up to 2 years
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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
Tijdsspanne: 3 months (+/- 3 weeks) from patient enrollment
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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.
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3 months (+/- 3 weeks) from patient enrollment
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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patient illness understanding and care preferences
Tijdsspanne: 3 months (+/- 3 weeks) from patient enrollment
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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
Tijdsspanne: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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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.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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change in patient distress
Tijdsspanne: baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
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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.
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baseline (time of enrollment) to 3 months (+/- 3 weeks) after enrollment
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change in patient depressive symptoms
Tijdsspanne: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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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.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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change in caregiver distress
Tijdsspanne: 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.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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change in caregiver burden
Tijdsspanne: baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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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.
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baseline (enrollment) to 3 months (+/- 3 weeks) after enrollment
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caregiver grief
Tijdsspanne: 1-3 months after death of enrolled patient
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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.
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1-3 months after death of enrolled patient
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change in caregiver anxiety symptoms
Tijdsspanne: 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
Tijdsspanne: 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
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caregiver perceptions of circumstances surrounding death and preparedness for death
Tijdsspanne: 1-3 months after death of enrolled patient
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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
Tijdsspanne: 3 months (+/- 3 weeks) after enrollment
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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.
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3 months (+/- 3 weeks) after enrollment
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patient emotional acceptance of illness
Tijdsspanne: 3 months (+/- 3 weeks) after enrollment
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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.
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3 months (+/- 3 weeks) after enrollment
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patient anxiety
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Yael Schenker, MD, MAS, University of Pittsburgh
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2013
Primaire voltooiing (Werkelijk)
1 augustus 2015
Studie voltooiing (Werkelijk)
1 augustus 2015
Studieregistratiedata
Eerst ingediend
7 juni 2013
Eerst ingediend dat voldeed aan de QC-criteria
24 juni 2013
Eerst geplaatst (Schatting)
25 juni 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
12 mei 2016
Laatste update ingediend die voldeed aan QC-criteria
10 mei 2016
Laatst geverifieerd
1 mei 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRO13020507
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