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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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Supportive Care Other: PSOPC pathway approach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 participants
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
Official Title: Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology & Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. Experiences in Close Relationships Inventory [ Time Frame: baseline, 1, 3, and 6 months ]
    Assessing how patients feel in close relationships with other people

  9. 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

  10. 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

  11. 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

  12. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03266276

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Principal Investigator: Janet Ellis, MD Sunnybrook Health Sciences Centre
Burlein-Hall, S. (January 2015). Unpublished data from Odette Cancer Centre symptom screening audit.
Cancer Quality Council of Ontario. Access to Psychosocial Oncology Service (2016.)
Cancer Care Ontario (2013) Psychosocial Oncology & Palliative Care Pathway: Disease Pathway Management.
Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2015. Toronto, On: Canadian Cancer Society;2015.
Cancer Care Ontario (2009). A Quality Initiative of the Program in Evidence-Based care (PEBC), Cancer care Ontario (CCO): The Management of Head and Neck Cancer in Ontario.
Cancer Quality Council of Ontario. Symptom Assessment and Management (2015).
Madeline Li, manuscript in preparation
Cancer Care Ontario (2013) Palliative Care Collaborative Plans CCPS: Condensed Version. https://
Palliative Performance Scale (PPSv2). Medical Care of the Dying,4th ed.; p120. Copyright Victoria Hospice Society,2006. accessed November 25,2015

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Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT03266276    
Other Study ID Numbers: 267-2016
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site