Assessing Impact of CCO's PSO & PC Pathway in Ambulatory HNC Clinics

January 25, 2024 updated by: Sunnybrook Health Sciences Centre

Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology & Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics

Rates of depression and anxiety in cancer patients are much higher compared to the general population. 40% of head and neck cancer patients will develop significant distress along the cancer journey. Less than half of these patients are able to access support, with factors such as age, social difficulty, cancer stage and site affecting referral. In 2016, 78,000 Canadians died of cancer, yet there is limited implementation of routine and integrated advanced care planning in cancer care.

An upcoming deliverable of all cancer centres in Ontario is the integration of Cancer Care Ontario's Psychosocial and Palliative Care (PSOPC) pathway into all disease pathways. Successful widespread implementation of this pathway at Odette Cancer Centre (OCC) will impact >16,000 patients/year. If effective, it will reduce suffering, unnecessary healthcare utilization, improve treatment decisions and compliance, enable a better quality of life in survivorship and improve quality at end of life. There is a need for better developed, standardized response pathways to address PSO and PC needs throughout the patient's journey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Head and neck cancer (HNC) is the sixth most commonly diagnosed cancer worldwide. Individuals with HNC experience a high burden of symptom-related distress (e.g. emotional, physical, psychological, spiritual etc.). Additionally, HNC patients may experience facial disfigurement, communication barriers, social stigma, lack of social support, and/or self-imposed or experienced disease stigma. The presence of depression, anxiety or social difficulty is relatively common in HNC patients yet less than half of those with significant distress access psychosocial (PSO) and palliative care (PC). Few studies have examined a systematic response to reducing distress, integrating a routine psychosocial and palliative care approach to oncology, with planning for future care for this population.

Most cancer centres do not have a systematic model of practice geared towards distress screening, PC and PSO approach to care. Therefore, determining how to best incorporate PSO and PC (PSOPC) into the interprofessional oncology clinic management of patients with HNC remains an important and unanswered question. The question remains of how to proactively identify those at higher risk for distress and greater need for specialized psychosocial or palliative care. Some oncologists consider the provision of PSOPC as an integral part of their professional role. Yet increasing the delivery of quality primary PSOPC by busy oncologists may require targeted training, the use of algorithms to prompt PC and PSO assessment, incorporating response to distress screening / advanced care planning tools into routine clinical processes, prompts to document conversations about illness understanding and consideration of individual factors influencing treatment decisions.

The primary goal of this study is to integrate quality primary level PSO and PC into clinic care by developing and evaluating a routine response to screening in hopes of increasing documentation of the following: discussion of response to ESAS, illness understanding, advanced care planning or goals of care conversations.

Specifically, this study will examine the impact of Cancer Care Ontario's (CCO) PSOPC Pathway, an expert panel recommended algorithm for assessing and managing symptoms and initiating a PSOPC approach and timely specialized referral, when necessary.

Phase Two: Randomized Controlled Trial

After completing the needs assessment and interprofessional team training in PSO and PC, an RCT will be used to examine the impact of using a standardized PSOPC pathway approach, prompted follow up with patients and documentation. Participants will be recruited and randomized into care as usual group and "intervention" PSOPC pathway group.

Main Hypothesis:

It is hypothesized that compared to treatment as usual, the PSOPC pathway intervention group will result in an increase in (larger proportion of):

Rationale and Objective:

Innovation: Model of clinical service delivery Currently, there is no standardized process for meeting the psychosocial and palliative care needs of HNC. This project promotes learner,needs-driven professional development, and knowledge translation. It will foster a person-focused, results-driven, integrated and sustainable model of clinical service delivery.

Individual clinics and cancer centres have developed their own responses to Edmonton Symptom Assessment System (ESAS) distress screening. However, we believe this project is a unique Oncology Team/PC/PSO/Patient Advisor collaboration, where all members will work together to improve symptom assessment and management, improve discussions and documentation involving illness understanding and advanced care planning to better meet PSO and PC needs, whilst assessing the role for the PSOPC Pathway.

An additional innovation for this project is to develop and evaluate a customizable approach to assessing the needs of an oncology team, thereby shaping both professional development experiences and determining a model of care delivery that should be acceptable within the clinic frame.

Improving Healthcare and Patient Experience:

The CCO PSOPC pathway was designed to guide improvements in the provision of primary PSOPC Care, including symptom response, communication, illness understanding, advanced care planning, as well as increased identification of those who require access to specialized PSO and PC beyond the skill set of the oncology team. An inaccurate illness understanding (whether the cancer is curable or not and whether it is progressing) hinders informed discussions and decisions and supportive end of life planning. And, while some patients with moderate to severe ESAS ratings have their symptoms assessed and managed, this is not the case for all patients. Earlier advanced care planning discussions help patients and their families have a better understanding of the disease to make more personalized, informed decisions about care.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Consenting ambulatory OCC HNC patients, with baseline ESAS scores of >2 (emotional) or >3 (physical symptoms) with no active suicidal ideation, cognitive impairment or significant debilitation such that participation would be burdensome for participants and/or safety concerns as determined by a research assistant.

Exclusion Criteria:

  • If participants endorse thoughts of dying at baseline, they will be asked to complete semi-structured questions to assess suicidal ideation (SI). If there is any active SI or intent, the oncology team will be informed, a record kept and the participant will be withdrawn from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as Usual Control Group
Treatment as usual.
Experimental: Intervention Group
Use of a standardized PSOPC pathway approach, prompted follow up with patients and documentation.
Other: PSOPC pathway approach

The intervention will use a standardized PSOPC pathway approach, prompted follow up with patients and documentation.

Additionally, clinicians will be prompted to document conversations about response to emotional or physical ESAS symptom scores, symptom management plan (self/education/monitoring/medication), illness understanding; and, if necessary, an offer of PSO/PC referral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)
Time Frame: baseline
Documented high ESAS scores (>6) and of all PPS scores, symptom management and conversations about PSO-either distress/management/referral/resources, PC needs, and ACP, illness understanding
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)
Time Frame: baseline, 1, 3, and 6 months

Valid and reliable 30-item questionnaire assessing health related quality of life

o 5 functional, 3 symptom, global HRQOL and single item scales
baseline, 1, 3, and 6 months
Princess Margaret Hospital Satisfaction with Doctor Questionnaire (PMH-PSQ 24)
Time Frame: baseline, 1, 3, and 6 months

PMH-PSQ 24 taps domains of Interpersonal skills, time spent with physician, information and physician relationship likert-type response scale (strongly agree/agree/disagree/strongly disagree/does not apply) consisting of 24 items (49)

o Measures two facets of satisfaction with care: physician disengagement and perceived support.
baseline, 1, 3, and 6 months
Mixed-methods interviews
Time Frame: 1 and 3 months

Mixed-methods interview questions assess patients' perceptions of their overall treatment experience and care received at OCC

  • 10 open-ended questions assessing patients' perceptions of the compassion and empathy received from HCPs
  • 10 questions taken from CCO's Person-Centered Care and Patient Experience with Outpatient Cancer Care Index assessing three dimensions of care: communication, self-management and support for shared decision-making
  • 31 questions taken the Ambulatory Oncology Patient Satisfaction Survey (AOPSS) assessing patients' perceptions of emotional support; information, communication and education; respect for patient preferences; coordination and continuity of care; physical comfort and access to care
  • 3 questions from iLead Champions Conversations With Patients assessing whether patients felt their personal needs were heard and met by HCPs during treatment
1 and 3 months
Patient Health Questionnaire (PHQ-9)
Time Frame: baseline, 1, 3, and 6 months
9 questions corresponding to the 9 diagnostic criteria for major depression DSMV as '0' (not at all) to '3' (nearly every day)
baseline, 1, 3, and 6 months
Beck Depression Inventory (BDI-II)
Time Frame: baseline, 1, 3, and 6 mnths
If depression/anxiety ESAS 3 or above, BDI to further assess depressive symptoms and assess for change in scores
baseline, 1, 3, and 6 mnths
General Anxiety Disorder (GAD-7)
Time Frame: baseline, 1, 3, and 6 months
To measure the severity of anxiety among patients 7-item tool based on DSM-V criteria has a scale similar to PHQ-9
baseline, 1, 3, and 6 months
Beck Anxiety Inventory (BAI)
Time Frame: baseline, 1, 3, and 6 months
If depression/anxiety ESAS 3 or above, BAI to further assess anxiety symptoms and assess for change in scores
baseline, 1, 3, and 6 months
Experiences in Close Relationships Inventory
Time Frame: baseline, 1, 3, and 6 months
Assessing how patients feel in close relationships with other people
baseline, 1, 3, and 6 months
Patient and, if participating, Caregiver Semi-structured interview
Time Frame: 1 and 3 months
A series of qualitative and quantitative questions assessing patients' experiences during care and caregivers' perceptions of quality of care, illness understanding and whether patient psychosocial and palliative needs were met during treatment
1 and 3 months
Edmonton Symptom Assessment System
Time Frame: baseline, 1 and 3 months
9 items designed to assess the severity of the most commonly reported symptoms experienced by cancer patients including pain, fatigue, drowsiness, nausea, dyspnea, depression, anxiety, well-being, and loss of appetite
baseline, 1 and 3 months
Palliative Performance Scale
Time Frame: baseline

Quantitatively represents a person's performance status and ability to function

  • 11 point scale from 100% (healthy) to 0% (death) with 10% decrements
  • The scale is based on five observable parameters: ambulation, ability to do activities, self-care, food/fluid intake, and consciousness level
baseline
Illness Understanding Questionnaire
Time Frame: 1, 3, and 6 months
A series of questions assessing patients' understanding of the course, nature and treatment of their illness
1, 3, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Janet Ellis, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2017

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

December 3, 2019

Study Registration Dates

First Submitted

August 25, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 267-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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