Clinical trial NCT02335619: Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients
Official title: Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total symptom distress score
timeFrame: 4 months after recruitment
Secondary outcomes:
measure: Use of health services
timeFrame: 4 months after recruitment
measure: Aggressiveness of cancer treatment
timeFrame: 4 months after recruitment
measure: Details of death (survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)
timeFrame: 1 year from recruitment
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
Study officials:
affiliation: British Columbia Cancer Agency
name: Philippa Hawley, B.Med
role: PRINCIPAL_INVESTIGATOR
References: