- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02668575
Integrating Supportive Care in Cystic Fibrosis
17 februari 2020 uppdaterad av: Dio Kavalieratos, PhD, University of Pittsburgh
Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease.
Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF.
The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF.
The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care.
Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden.
This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
As described above.
Studietyp
Interventionell
Inskrivning (Faktisk)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Ability to comprehend English
- Advanced CF
(Any of the following criteria will be indicative of "Advanced CF")
- Baseline supplemental oxygen requirement
- FEV1 ≤ 50%
- Baseline non-invasive mechanical ventilation requirement
- ≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF
Exclusion Criteria:
- Prisoners
- Females who are pregnant
- Prior receipt of specialist SC services
- Cognitive impairments
- Patients younger than 18 years of age
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Usual Care
Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center.
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Experimentell: Supportive Care Intervention
Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.
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Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis.
Using a structured intervention manual, these visits will span 30-60 minutes each.
Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience.
Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Feasibility of intervention
Tidsram: Up to 9 months (+/- 4 weeks)
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Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
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Up to 9 months (+/- 4 weeks)
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Acceptability of intervention
Tidsram: Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse the intervention as acceptable.
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Up to 9 months (+/- 4 weeks)
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Perceived effectiveness of intervention
Tidsram: Up to 9 months (+/- 4 weeks)
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Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
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Up to 9 months (+/- 4 weeks)
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Intervention fidelity
Tidsram: Up to 9 months (+/- 4 weeks)
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Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
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Up to 9 months (+/- 4 weeks)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Tidsram: Up to 9 months (+/- 4 weeks)
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Change in QOL from baseline as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Patient mood
Tidsram: Up to 9 months (+/- 4 weeks)
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Change in mood from baseline using the Hospital Anxiety and Depression Scale (HADS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Coping style
Tidsram: Up to 9 months (+/- 4 weeks)
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Change in coping style from baseline using the Brief COPE, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Satisfaction with care
Tidsram: Up to 9 months (+/- 4 weeks)
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Change in satisfaction with care from baseline using the FAMCARE-P13, reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Symptom burden
Tidsram: Up to 9 months (+/- 4 weeks)
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Change in symptom burden from baseline using the Edmonton Symptom Assessment Scale (ESAS), reported at 0, 3, 6, 9 months.
Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
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Up to 9 months (+/- 4 weeks)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Healthcare utilization
Tidsram: Up to 12 months
|
The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.
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Up to 12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Dio Kavalieratos, PhD, Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
- Huvudutredare: Joseph Pilewski, MD, Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 mars 2016
Primärt slutförande (Faktisk)
29 november 2018
Avslutad studie (Faktisk)
7 oktober 2019
Studieregistreringsdatum
Först inskickad
14 januari 2016
Först inskickad som uppfyllde QC-kriterierna
26 januari 2016
Första postat (Uppskatta)
29 januari 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB#: PRO14110168
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis.
This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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