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Early Palliative Care on Quality of Life of Advanced Cancer Patients

NCT ID: NCT02988635

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-11-30

Brief Summary

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This study compares two types of care - Standard Oncology Care (SOC) and SOC with early palliative care (EPC) (started within 8 weeks after diagnosis of advanced disease) to see which is better for improving the quality of life of patients with advanced lung, pancreas, gastric and biliary tract cancer. The study will use FACT-G questionnaire to measure patients' quality of life.

Detailed Description

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The patients will complete a baseline FACT-G questionnaire and then will be randomized to a study group.

Subjects who are randomized to Standard Oncology Care (SOC) will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist or of the family. They will complete FACT-G questionnaire at 12 weeks after enrollment.

Subjects who are randomized to the SOC with Early Palliative Care (EPC) will meet with a palliative care team (basically composed by a palliative care physician and a palliative care specialized nurse) at their next medical oncology or infusion visit. They will meet with the palliative care team at least every three weeks. They will complete FACT-G questionnaire at 12 weeks after enrollment.

Conditions

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Non-small Cell Lung Cancer Gastric Cancer Pancreatic Cancer Biliary Tract Cancer

Keywords

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Early Palliative Care Simultaneous Care Chemotherapy Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early Palliative Care

Subjects receive standard of care with early palliative care.

Group Type EXPERIMENTAL

Early Palliative Care

Intervention Type OTHER

Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.

Standard of Care

Subjects receive standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early Palliative Care

Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed metastatic lung (NSCLC), pancreatic, gastric and biliary tract cancer, diagnosed within the previous 8 weeks; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; age ± 18 years; metastatic or locally advanced disease (but not susceptible of loco-regional treatments); eligibility to first-line chemotherapy ± biological agents; life expectancy more than three months; written informed consent provided; FACT-G questionnaire filled in at enrollment, before the randomization.

Exclusion Criteria

* Patients already receiving care from the PC service or pretreated with chemotherapy ± biological
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regione Emilia-Romagna

OTHER

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role lead

Responsible Party

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Vittorio Franciosi

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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VITTORIO FRANCIOSI, M.D.

Role: PRINCIPAL_INVESTIGATOR

UO ONCOLOGIA MEDICA, AZIENDA OSPEDALIERO-UNIVERSITARIA, PARMA, ITALY

Other Identifiers

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RERSCE35E13

Identifier Type: -

Identifier Source: org_study_id