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

NCT03837132 | Completed

• 1 other identifier: H2018:291
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Advanced Pancreatic Cancer; Early Palliative Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Impact of early palliative care on quality of life in patients with advanced pancreatic cancer

  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.

  registration to 16 weeks

Secondary Outcomes (1)

• To explore the impact of early palliative care on symptom management, depression, anxiety and survival in patients with advanced pancreatic cancer

  registration to 16 weeks

Study Arms (1)

Advanced pancreatic cancers

Newly diagnosed patients with advanced pancreatic cancer

Behavioral: Palliative care assessment

Interventions

Palliative care assessment BEHAVIORAL

Patients with advanced pancreatic cancer will have regular palliative care assessment with palliative care team

Also known as: Early palliative care assessment

Advanced pancreatic cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed advanced adult pancreatic patients

You may qualify if:

• 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

You may not qualify if:

• age \<18
• receiving cycle 2 of chemotherapy

Sponsors & Collaborators

• University of Manitoba: lead
• CancerCare Manitoba: collaborator
• Celgene: collaborator

Study Sites (1)

Victoria General Hospital Buhler Cancer Centre

Winnipeg, Manitoba, R3T 2E8, Canada

Location

Related Publications (1)

• Kim CA, Lelond S, Daeninck PJ, Rabbani R, Lix L, McClement S, Chochinov HM, Goldenberg BA. The impact of early palliative care on the quality of life of patients with advanced pancreatic cancer: The IMPERATIVE case-crossover study. Support Care Cancer. 2023 Apr 6;31(4):250. doi: 10.1007/s00520-023-07709-3.

  PMID: 37022483 DERIVED

Study Officials

• Christina Kim, MD FRCPC

  CancerCare Manitoba/ University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, CancerCare Manitoba; Assistant Professor, University of Manitoba

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: February 11, 2019
• Study Start: October 15, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)