Assessing Impact of CCO's PSO & PC Pathway in Ambulatory HNC Clinics
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|ClinicalTrials.gov Identifier: NCT03266276|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2017
Last Update Posted : June 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|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|
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.
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03266276
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N3M5|
|Principal Investigator:||Janet Ellis, MD||Sunnybrook Health Sciences Centre|