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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03266276
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : June 24, 2019
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE August 25, 2017
First Posted Date  ICMJE August 30, 2017
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE October 10, 2017
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03266276 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • 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
  • 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.
  • 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
  • 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)
  • 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
  • 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
  • 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
  • Experiences in Close Relationships Inventory [ Time Frame: baseline, 1, 3, and 6 months ]
    Assessing how patients feel in close relationships with other people
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Assessing Impact of CCO's PSO & PC Pathway in Ambulatory HNC Clinics
Official Title  ICMJE Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology & Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized Controlled Trial

After completing HNC staff 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 (1) care as usual group and (2) "intervention" PSOPC pathway group.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Head and Neck Cancer
  • Supportive Care
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: PSOPC pathway approach
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03266276
Other Study ID Numbers  ICMJE 267-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Janet Ellis, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP