Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

January 23, 2020 updated by: Pippa Hawley

Currently at the BC Cancer Agency, oncologists decide when to refer a patient to the Pain and Symptom Management/Palliative Care (PSMPC) team, and their decisions are made subjectively and without standard guidelines/symptom assessment tools. Patients are often referred late in their treatment. The PSMPC team sees patients in their own clinic, separately from the oncologists, and do not often collaborate in a patient's care.

Early integration of palliative care into oncological care has been shown to improve quality of life and to prolong survival, as well as to reduce inappropriately aggressive oncological care at end of life, and reduce costs of care. We will test an early oncology-integrated palliative care model, with the aims of determining whether 1) the introduction of PSMPC support at the time of diagnosis leads to better symptom management and quality of life of patients, 2) early integration of palliative care into medical oncology care reduces aggressiveness of cancer treatment near end of life, and 3) a fully integrated service delivery model is sustainable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal (GI) medical oncologists will be assigned to intervention or control groups, according to whether or not they have clinics scheduled on 2 specific half days each week, to coincide with PSMPC clinics. New patients attending the specified clinics under each oncologist will be automatically fall under whichever group their oncologist has been assigned. Control patients will be those seen at clinics other than the 2 specified intervention clinics.

Patients will be approached for study participation in the waiting room of the GI clinic as they await their first oncology appointment. Those who agree to participate will be asked to complete a symptom assessment questionnaire at baseline and once a month for 4 months. This timing is meant to coincide with their regularly scheduled follow up appointments with the GI oncologist.

Symptom scores from the completed assessment forms will be entered into a study database, created with the BC Cancer Agency IDs of the study participants alongside an anonymized study ID.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with a gastrointestinal (GI) cancer
  • have appointments in GI clinic during study days
  • able to complete a symptom assessment form on their own or with the help of a family member or interpreter

Exclusion Criteria:

  • already receiving care from the Pain and Symptom Management/Palliative Care team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early Palliative Care
During their first oncology appointment, the intervention arm patients will self-report any symptoms related to their cancer or treatment to the study team; scores at or above a defined benchmark will be seen by Pain and Symptom Management/Palliative Care team members during or immediately after their oncology appointment. Patients will be asked to self-report symptoms once a month following recruitment, for 4 months.
Behavioral: Early palliative care
No Intervention: Standard Care
During their first oncology appointment, the control arm patients will self-report any symptoms related to their cancer or treatment to the study team; self-reports will be collected but not shared with the Pain and Symptom Management/Palliative Care team, and patients will continue with their oncology appointment as per standard procedure. Patients will be asked to self-report symptoms once a month following recruitment, for 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total symptom distress score
Time Frame: 4 months after recruitment
Total symptom distress score will be measured using a modified Edmonton Symptom Assessment System (ESAS). Individual patient scores at 4 months will be compared to their scores at recruitment (first oncology appointment).
4 months after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of health services
Time Frame: 4 months after recruitment

This outcome will be evaluated by measuring the following within each treatment group:

number of hospital admissions for non-treatment reasons; number of emergency room visits; number of referrals to the Pain and Symptom Management/Palliative Care team; number of Pain and Symptom Management/Palliative Care follow up visits per patient
4 months after recruitment
Aggressiveness of cancer treatment
Time Frame: 4 months after recruitment

This outcome will be evaluated by measuring the following within each treatment group:

number of patients being treated with chemotherapy in last 2-4 weeks of life; number of patients admitted to home hospice in last 3-14 days of life
4 months after recruitment
Details of death (survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)
Time Frame: 1 year from recruitment

This data will be collected for those patients who do not survive past one year of recruitment. The outcome will be evaluated by the following:

survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)
1 year from recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pippa Hawley

Investigators

  • Principal Investigator: Philippa Hawley, B.Med, British Columbia Cancer Agency

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-02082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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