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

Primary Purpose

Head and Neck Cancer, Supportive Care

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PSOPC pathway approach
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 If there is any active SI or intent, the oncology team will be informed, a record kept and the participant will be withdrawn from the study.

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual Control Group

Intervention Group

Arm Description

Treatment as usual.

Use of a standardized PSOPC pathway approach, prompted follow up with patients and documentation.

Outcomes

Primary Outcome Measures

Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)
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

The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)
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)
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
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)
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)
If depression/anxiety ESAS 3 or above, BDI to further assess depressive symptoms and assess for change in scores
General Anxiety Disorder (GAD-7)
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)
If depression/anxiety ESAS 3 or above, BAI to further assess anxiety symptoms and assess for change in scores
Experiences in Close Relationships Inventory
Assessing how patients feel in close relationships with other people
Patient and, if participating, Caregiver Semi-structured interview
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
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
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
A series of questions assessing patients' understanding of the course, nature and treatment of their illness

Full Information

First Posted
August 25, 2017
Last Updated
June 20, 2019
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03266276
Brief Title
Assessing Impact of CCO's PSO & PC Pathway in Ambulatory HNC Clinics
Official Title
Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology & Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Supportive Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual Control Group
Arm Type
No Intervention
Arm Description
Treatment as usual.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Use of a standardized PSOPC pathway approach, prompted follow up with patients and documentation.
Intervention Type
Other
Intervention Name(s)
PSOPC pathway approach
Intervention Description
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 Measure Information:
Title
Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP)
Description
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
Time Frame
baseline
Secondary Outcome Measure Information:
Title
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)
Description
Valid and reliable 30-item questionnaire assessing health related quality of life o 5 functional, 3 symptom, global HRQOL and single item scales
Time Frame
baseline, 1, 3, and 6 months
Title
Princess Margaret Hospital Satisfaction with Doctor Questionnaire (PMH-PSQ 24)
Description
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.
Time Frame
baseline, 1, 3, and 6 months
Title
Mixed-methods interviews
Description
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
Time Frame
1 and 3 months
Title
Patient Health Questionnaire (PHQ-9)
Description
9 questions corresponding to the 9 diagnostic criteria for major depression DSMV as '0' (not at all) to '3' (nearly every day)
Time Frame
baseline, 1, 3, and 6 months
Title
Beck Depression Inventory (BDI-II)
Description
If depression/anxiety ESAS 3 or above, BDI to further assess depressive symptoms and assess for change in scores
Time Frame
baseline, 1, 3, and 6 mnths
Title
General Anxiety Disorder (GAD-7)
Description
To measure the severity of anxiety among patients 7-item tool based on DSM-V criteria has a scale similar to PHQ-9
Time Frame
baseline, 1, 3, and 6 months
Title
Beck Anxiety Inventory (BAI)
Description
If depression/anxiety ESAS 3 or above, BAI to further assess anxiety symptoms and assess for change in scores
Time Frame
baseline, 1, 3, and 6 months
Title
Experiences in Close Relationships Inventory
Description
Assessing how patients feel in close relationships with other people
Time Frame
baseline, 1, 3, and 6 months
Title
Patient and, if participating, Caregiver Semi-structured interview
Description
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
Time Frame
1 and 3 months
Title
Edmonton Symptom Assessment System
Description
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
Time Frame
baseline, 1 and 3 months
Title
Palliative Performance Scale
Description
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
Time Frame
baseline
Title
Illness Understanding Questionnaire
Description
A series of questions assessing patients' understanding of the course, nature and treatment of their illness
Time Frame
1, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Ellis, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Assessing Impact of CCO's PSO & PC Pathway in Ambulatory HNC Clinics

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