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Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

Primary Purpose

Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Early palliative care
Sponsored by
Pippa Hawley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Cancer Agency - Vancouver Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Early Palliative Care

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
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)

Full Information

First Posted
January 7, 2015
Last Updated
January 23, 2020
Sponsor
Pippa Hawley
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1. Study Identification

Unique Protocol Identification Number
NCT02335619
Brief Title
Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients
Official Title
Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pippa Hawley

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Palliative Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early palliative care
Primary Outcome Measure Information:
Title
Total symptom distress score
Description
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).
Time Frame
4 months after recruitment
Secondary Outcome Measure Information:
Title
Use of health services
Description
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
Time Frame
4 months after recruitment
Title
Aggressiveness of cancer treatment
Description
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
Time Frame
4 months after recruitment
Title
Details of death (survival time from first oncology appointment at BC Cancer location of death (home, hospice, Cancer Centre)
Description
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)
Time Frame
1 year from recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippa Hawley, B.Med
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Integrated Supportive Care Study for Gastrointestinal Cancer Patients

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