Skip to main content
OpenTrials
Completed

NCT Number: NCT02335619

Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early palliative care

Behavioral

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Pippa Hawley

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 12, 2015
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.