Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

NCT02335619 | Completed

• 1 other identifier: H14-02082
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Use of health services

  4 months after recruitment

• Aggressiveness of cancer treatment

  4 months after recruitment

• Details of death (survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)

  1 year from recruitment

Study Arms (2)

Early Palliative Care

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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.

Interventions

Early palliative care BEHAVIORAL

Early Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pippa Hawley: lead

Study Sites (1)

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Philippa Hawley, B.Med

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Palliative Care Physician

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 12, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)