Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

Cancer Clinical Trial

Official title:

Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335619
• Other study ID #: H14-02082
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: April 2019

Study information

• Verified date: January 2020
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• Early palliative care

Locations

Country	Name	City	State
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pippa Hawley

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total symptom distress score	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	Use of health services	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
Secondary	Aggressiveness of cancer treatment	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
Secondary	Details of death (survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)	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