Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients

Study Overview
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Brief Summary
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This is a randomized controlled trial comparing a web-based psychosocial screening application to usual care in a cohort of surgically-treated head and neck cancer patients to determine its efficacy in monitoring depression and distress, and prompting necessary psychiatry/psychology referrals. In addition, treatment adherence, rehabilitation and return to work, primary care utilization, and survival will be monitored.

Detailed Description
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This is a randomized controlled trial comparing a web-based psychosocial screening application to usual care in a cohort of surgically-treated head and neck cancer patients. This study will utilize a web-based application available on desktop or laptop computers, and smartphones. The application involves monitoring using the NCCN Distress Thermometer Score, the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) score, and the Head and Neck Research Network (HNRN-33), a patient-reported, validated functional outcomes score. These assessments will be completed at baseline, 2 weeks postoperatively, and monthly thereafter until 12 months. Patients will have the option of filling out questionnaires more frequently if desired. This web-based application, the NAPT App, will allow patients to alert the treatment team of their current state of mood or distress. Automatic alerts will be sent to the team if a Distress Score of </=3, a QIDS score >/=11, or suicidal ideation are expressed in the application. The study duration will be 12 months with a primary endpoint of 6 months. Our primary outcome will be NCCN Distress Thermometer Score at 6 months, with secondary outcomes of the QIDS and HNRN-33 functional scores at 6 and 12 months. Additional outcomes assessed will pertain to completion of adjuvant therapy, weight maintenance, rehabilitation and return to work, and survival. Health services delivery outcomes, such as primary care visits, emergency department visits, hospitalizations, and narcotic use will also be evaluated.

Official Title
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Northern Alberta Psychosocial Telecare (NAPT) Screening for Surgical Head and Neck Cancer Patients: a Randomized Controlled Trial

Conditions
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Cancer Distress

Intervention / Treatment
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* Other: NAPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years New (non-recurrent) head and neck cancer Primary surgical treatment Exclusion Criteria: <18 years Recurrent head and neck cancer Previous chemotherapy or radiation therapy History of psychiatric or psychologic illness History of previous cancers or cancer distress

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Group<br>The Usual Care Group will include adult patients undergoing primary surgical treatment for head and neck cancer. Supportive care will be offered or provided according to patients' wishes. | |
| Active Comparator: NAPT Group<br>The NAPT Group will include adult patients undergoing primary surgical treatment for head and neck cancer. Patients will be given access to a web-based application that monitors depression, distress, and functional outcomes scores at regular intervals for 12 months. Patients will be able to alert the treatment team of decreased mood, increased distress, and functional issues impacting both. Patients will also be able to track their mood and distress levels throughout the 12 months and involve care-givers in monitoring as well. | Other: NAPT<br>* Web-based depression and distress monitoring application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress Thermometer Score | NCCN Distress Thermometer Score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QIDS Score | Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) | 6 and 12 months | 
| HNRN-33 | Head and Neck Research Network (HNRN-33) | 6 and 12 months | 
| Completion of Adjuvant Therapy | Completion of Adjuvant Therapy, including radiation or chemotherapy | 6 months | 
| Return to work | Return to work by 12 months | 12 months | 
| Hospital Readmissions | Hospital Readmissions | 12 months | 
| Primary Care Visits | Primary Care Visits to Family Physician | 12 months | 
| Emergency Department Visits | Emergency Department Visits | 12 months |