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Early Palliative Care on Quality of Life of Patients With Advanced Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03837132
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
CancerCare Manitoba
Celgene
Information provided by (Responsible Party):
Christina Kim, University of Manitoba

Brief Summary:
The primary objective is to explore the impact of early palliative care on quality of life in patients with advanced pancreatic cancer. The secondary objectives are to explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer.

Condition or disease Intervention/treatment
Advanced Cancer Behavioral: Palliative care assessment

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Impact of Early Palliative Care on the Quality of Life of Patients With Advanced Pancreas Cancer: A Case-crossover Study
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 30, 2020


Group/Cohort Intervention/treatment
Advanced pancreatic cancers
Newly diagnosed patients with advanced pancreatic cancer
Behavioral: Palliative care assessment
Patients with advanced pancreatic cancer will have regular palliative care assessment with palliative care team
Other Name: Early palliative care assessment




Primary Outcome Measures :
  1. Impact of early palliative care on quality of life in patients with advanced pancreatic cancer [ Time Frame: registration to 16 weeks ]
    For the primary endpoint, we will use a generalized linear model to test for a statistically significant change score between baseline and 16 weeks. We will assume a normal distribution for the change scores. Model fit will be assessed via a visual assessment of residuals and the ratio of the model deviance to its degrees of freedom.


Secondary Outcome Measures :
  1. To explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer [ Time Frame: registration to 16 weeks ]
    Secondary endpoints will include: (1) symptom control at 16 weeks as measured by the revised Edmonton Symptom Assessment Scale (ESAS-r) (a widely used and validated tool to assess symptom intensity, which is routinely completed by patients at all CCMB visits); (2) depression and anxiety at 16 weeks using the Hospital Anxiety and Depression Scale (HADS) (a 14 item scale which can be used in the outpatient setting to screen for anxiety and depression within the previous week) and the Patient Health Questionnaire (PHQ-9) (a sensitive (88%) and specific (88%) 9 question tool which incorporates diagnostic criteria for major depression); and overall survival measured from date of registration to death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed advanced adult pancreatic patients
Criteria

Inclusion Criteria:

  • age >18
  • newly diagnosed advanced pancreatic cancer (APC)
  • English speaking or willing to be seen with a medical interpreter
  • willing and able to complete quality of life (QoL) questionnaires

Exclusion Criteria:

  • age <18
  • receiving cycle 2 of chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837132


Contacts
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Contact: Christina Kim, MD FRCPC 204-237-2006 ckim3@cancercare.mb.ca

Locations
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Canada, Manitoba
Victoria General Hospital Buhler Cancer Centre Recruiting
Winnipeg, Manitoba, Canada, R3T 2E8
Contact: Christina Kim, MD FRCPC    204-237-2006    ckim3@cancercare.mb.ca   
Contact: Stephanie Lelond, RN, BN    204-477-3477    slelond2@cancercare.mb.ca   
Sponsors and Collaborators
University of Manitoba
CancerCare Manitoba
Celgene
Investigators
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Principal Investigator: Christina Kim, MD FRCPC CancerCare Manitoba/ University of Manitoba

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Responsible Party: Christina Kim, Medical Oncologist, CancerCare Manitoba; Assistant Professor, University of Manitoba, University of Manitoba
ClinicalTrials.gov Identifier: NCT03837132     History of Changes
Other Study ID Numbers: H2018:291
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Kim, University of Manitoba:
Advanced Pancreatic Cancer
Early Palliative Care
Quality of Life
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancrelipase
Gastrointestinal Agents