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Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02335619
Enrollment
176
Registered
2015-01-12
Start date
2015-02-28
Completion date
2019-04-30
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

Sponsors

Pippa Hawley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total symptom distress score4 months after recruitmentTotal 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

MeasureTime frameDescription
Use of health services4 months after recruitmentThis 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
Aggressiveness of cancer treatment4 months after recruitmentThis 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
Details of death (survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)1 year from recruitmentThis 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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026