Head and Neck CancerNCT03266276
Assessing Impact of CCO's PSO & PC Pathway in Ambulatory HNC Clinics
A study testing PSOPC pathway approach in people with Head and Neck Cancer and Supportive Care, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head and Neck Cancer, Supportive Care
- What is being tested?
- PSOPC pathway approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2017to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 If there is any active SI or intent, the oncology team will be informed, a record kept and the participant will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer, Supportive Care
- Being tested
- PSOPC pathway approach
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSOPC pathway approachOther
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 group | Role | What they receive |
|---|---|---|
| Treatment as Usual Control Group | No intervention | Treatment as usual. |
| Intervention Group | Experimental | Use of a standardized PSOPC pathway approach, prompted follow up with patients and documentation. Receives: Other: PSOPC pathway approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (12)
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
- 5 functional, 3 symptom, global HRQOL and single item scales
Measured: baseline, 1, 3, and 6 months
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)
- Measures two facets of satisfaction with care: physician disengagement and perceived support.
Measured: baseline, 1, 3, and 6 months
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
Measured: 1 and 3 months
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)
Measured: baseline, 1, 3, and 6 months
Beck Depression Inventory (BDI-II)
If depression/anxiety ESAS 3 or above, BDI to further assess depressive symptoms and assess for change in scores
Measured: baseline, 1, 3, and 6 mnths
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
Measured: baseline, 1, 3, and 6 months
Beck Anxiety Inventory (BAI)
If depression/anxiety ESAS 3 or above, BAI to further assess anxiety symptoms and assess for change in scores
Measured: baseline, 1, 3, and 6 months
Experiences in Close Relationships Inventory
Assessing how patients feel in close relationships with other people
Measured: baseline, 1, 3, and 6 months
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
Measured: 1 and 3 months
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
Measured: baseline, 1 and 3 months
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
Measured: baseline
Illness Understanding Questionnaire
A series of questions assessing patients' understanding of the course, nature and treatment of their illness
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start10 Oct 2017
- Primary completion29 Nov 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet Ellis, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266276
- Sponsor's protocol ID
- 267-2016
- Status last verified
- Jan 2024
- First submitted
- 25 Aug 2017
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ortholan C, Benezery K, Dassonville O, Poissonnet G, Bozec A, Guiochet N, Belkacemi Y. A specific approach for elderly patients with head and neck cancer. Anticancer Drugs. 2011 Aug;22(7):647-55. doi: 10.1097/CAD.0b013e328344282a.
PubMed 21394019Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008 May 17;371(9625):1695-709. doi: 10.1016/S0140-6736(08)60728-X.
PubMed 18486742Devins GM, Payne AY, Lebel S, Mah K, Lee RN, Irish J, Wong J, Rodin GM. The burden of stress in head and neck cancer. Psychooncology. 2013 Mar;22(3):668-76. doi: 10.1002/pon.3050. Epub 2012 Mar 5.
PubMed 22392570Burlein-Hall, S. (January 2015). Unpublished data from Odette Cancer Centre symptom screening audit.
Rhoten BA, Deng J, Dietrich MS, Murphy B, Ridner SH. Body image and depressive symptoms in patients with head and neck cancer: an important relationship. Support Care Cancer. 2014 Nov;22(11):3053-60. doi: 10.1007/s00520-014-2312-2. Epub 2014 Jun 14.
PubMed 24925049Lebel S, Castonguay M, Mackness G, Irish J, Bezjak A, Devins GM. The psychosocial impact of stigma in people with head and neck or lung cancer. Psychooncology. 2013 Jan;22(1):140-52. doi: 10.1002/pon.2063. Epub 2011 Sep 19.
PubMed 21932417Weiner B, Perry RP, Magnusson J. An attributional analysis of reactions to stigmas. J Pers Soc Psychol. 1988 Nov;55(5):738-48. doi: 10.1037//0022-3514.55.5.738.
PubMed 2974883Else-Quest NM, LoConte NK, Schiller JH, Hyde JS. Perceived stigma, self-blame, and adjustment among lung, breast and prostate cancer patients. Psychol Health. 2009 Oct;24(8):949-64. doi: 10.1080/08870440802074664.
PubMed 20205038Bultz BD, Waller A, Cullum J, Jones P, Halland J, Groff SL, Leckie C, Shirt L, Blanchard S, Lau H, Easaw J, Fassbender K, Carlson LE. Implementing routine screening for distress, the sixth vital sign, for patients with head and neck and neurologic cancers. J Natl Compr Canc Netw. 2013 Oct 1;11(10):1249-61. doi: 10.6004/jnccn.2013.0147.
PubMed 24142826Hammerlid E, Ahlner-Elmqvist M, Bjordal K, Biorklund A, Evensen J, Boysen M, Jannert M, Kaasa S, Sullivan M, Westin T. A prospective multicentre study in Sweden and Norway of mental distress and psychiatric morbidity in head and neck cancer patients. Br J Cancer. 1999 May;80(5-6):766-74. doi: 10.1038/sj.bjc.6690420.
PubMed 10360654Oishi A, Murtagh FE. The challenges of uncertainty and interprofessional collaboration in palliative care for non-cancer patients in the community: a systematic review of views from patients, carers and health-care professionals. Palliat Med. 2014 Oct;28(9):1081-98. doi: 10.1177/0269216314531999. Epub 2014 May 12.
PubMed 24821710Vigano A, Dorgan M, Buckingham J, Bruera E, Suarez-Almazor ME. Survival prediction in terminal cancer patients: a systematic review of the medical literature. Palliat Med. 2000 Sep;14(5):363-74. doi: 10.1191/026921600701536192.
PubMed 11064783Cancer Quality Council of Ontario. Access to Psychosocial Oncology Service (2016.) http://www.csqi.on.ca/by_patients_journey/diagnosis/acess_to_psychosocial_oncology_services/
Dansky Ullmann C, Harlan LC, Shavers VL, Stevens JL. A population-based study of therapy and survival for patients with head and neck cancer treated in the community. Cancer. 2012 Sep 15;118(18):4452-61. doi: 10.1002/cncr.27419. Epub 2012 Jan 17.
PubMed 22252676Turnbull Macdonald GC, Baldassarre F, Brown P, Hatton-Bauer J, Li M, Green E, Lebel S. Psychosocial care for cancer: a framework to guide practice, and actionable recommendations for Ontario. Curr Oncol. 2012 Aug;19(4):209-16. doi: 10.3747/co.19.981.
PubMed 22876147
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Cancer Care Ontario's Psychosocial Oncology & Palliative Care Pathway in Ambulatory Head and Neck Cancer Clinics
- ClinicalTrials.gov ID
- NCT03266276
- Acronym / sponsor ID
- 267-2016
- Conditions
- Head and Neck Cancer, Supportive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual Control Group | No intervention | –Treatment as usual. |
| Intervention Group | Experimental | Other: PSOPC pathway approachUse of a standardized PSOPC pathway approach, prompted follow up with patients and documentation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSOPC pathway approachThe 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. | Other | Intervention Group |
Primary outcome
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
12 secondary outcomes
The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QOL 30)
Time frame: baseline, 1, 3, and 6 months
Princess Margaret Hospital Satisfaction with Doctor Questionnaire (PMH-PSQ 24)
Time frame: baseline, 1, 3, and 6 months
Mixed-methods interviews
Time frame: 1 and 3 months
Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 1, 3, and 6 months
Beck Depression Inventory (BDI-II)
Time frame: baseline, 1, 3, and 6 mnths
General Anxiety Disorder (GAD-7)
Time frame: baseline, 1, 3, and 6 months
Beck Anxiety Inventory (BAI)
Time frame: baseline, 1, 3, and 6 months
Experiences in Close Relationships Inventory
Time frame: baseline, 1, 3, and 6 months
Patient and, if participating, Caregiver Semi-structured interview
Time frame: 1 and 3 months
Edmonton Symptom Assessment System
Time frame: baseline, 1 and 3 months
Palliative Performance Scale
Time frame: baseline
Illness Understanding Questionnaire
Time frame: 1, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 21394019Ortholan C, Benezery K, Dassonville O, Poissonnet G, Bozec A, Guiochet N, Belkacemi Y. A specific approach for elderly patients with head and neck cancer. Anticancer Drugs. 2011 Aug;22(7):647-55. doi: 10.1097/CAD.0b013e328344282a.
- Background: PubMed 18486742Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008 May 17;371(9625):1695-709. doi: 10.1016/S0140-6736(08)60728-X.
- Background: PubMed 22392570Devins GM, Payne AY, Lebel S, Mah K, Lee RN, Irish J, Wong J, Rodin GM. The burden of stress in head and neck cancer. Psychooncology. 2013 Mar;22(3):668-76. doi: 10.1002/pon.3050. Epub 2012 Mar 5.
- BackgroundBurlein-Hall, S. (January 2015). Unpublished data from Odette Cancer Centre symptom screening audit.
- Background: PubMed 24925049Rhoten BA, Deng J, Dietrich MS, Murphy B, Ridner SH. Body image and depressive symptoms in patients with head and neck cancer: an important relationship. Support Care Cancer. 2014 Nov;22(11):3053-60. doi: 10.1007/s00520-014-2312-2. Epub 2014 Jun 14.
- Background: PubMed 21932417Lebel S, Castonguay M, Mackness G, Irish J, Bezjak A, Devins GM. The psychosocial impact of stigma in people with head and neck or lung cancer. Psychooncology. 2013 Jan;22(1):140-52. doi: 10.1002/pon.2063. Epub 2011 Sep 19.
- Background: PubMed 2974883Weiner B, Perry RP, Magnusson J. An attributional analysis of reactions to stigmas. J Pers Soc Psychol. 1988 Nov;55(5):738-48. doi: 10.1037//0022-3514.55.5.738.
- Background: PubMed 20205038Else-Quest NM, LoConte NK, Schiller JH, Hyde JS. Perceived stigma, self-blame, and adjustment among lung, breast and prostate cancer patients. Psychol Health. 2009 Oct;24(8):949-64. doi: 10.1080/08870440802074664.
- Background: PubMed 24142826Bultz BD, Waller A, Cullum J, Jones P, Halland J, Groff SL, Leckie C, Shirt L, Blanchard S, Lau H, Easaw J, Fassbender K, Carlson LE. Implementing routine screening for distress, the sixth vital sign, for patients with head and neck and neurologic cancers. J Natl Compr Canc Netw. 2013 Oct 1;11(10):1249-61. doi: 10.6004/jnccn.2013.0147.
- Background: PubMed 10360654Hammerlid E, Ahlner-Elmqvist M, Bjordal K, Biorklund A, Evensen J, Boysen M, Jannert M, Kaasa S, Sullivan M, Westin T. A prospective multicentre study in Sweden and Norway of mental distress and psychiatric morbidity in head and neck cancer patients. Br J Cancer. 1999 May;80(5-6):766-74. doi: 10.1038/sj.bjc.6690420.
- Background: PubMed 24821710Oishi A, Murtagh FE. The challenges of uncertainty and interprofessional collaboration in palliative care for non-cancer patients in the community: a systematic review of views from patients, carers and health-care professionals. Palliat Med. 2014 Oct;28(9):1081-98. doi: 10.1177/0269216314531999. Epub 2014 May 12.
- Background: PubMed 11064783Vigano A, Dorgan M, Buckingham J, Bruera E, Suarez-Almazor ME. Survival prediction in terminal cancer patients: a systematic review of the medical literature. Palliat Med. 2000 Sep;14(5):363-74. doi: 10.1191/026921600701536192.
- Individual participant dataSharing planned: No
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Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Ellis, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSOPC pathway approach in people with Head and Neck Cancer and Supportive Care, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased documentation of response to symptoms (ESAS), PPS, illness understanding and advanced care planning (ACP) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266276, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.