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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Web-based depression and distress monitoring application
University of Alberta
Edmonton, Alberta, Canada
RECRUITINGDistress Thermometer Score
NCCN Distress Thermometer Score
Time frame: 6 months
QIDS Score
Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
Time frame: 6 and 12 months
HNRN-33
Head and Neck Research Network (HNRN-33)
Time frame: 6 and 12 months
Completion of Adjuvant Therapy
Completion of Adjuvant Therapy, including radiation or chemotherapy
Time frame: 6 months
Return to work
Return to work by 12 months
Time frame: 12 months
Hospital Readmissions
Hospital Readmissions
Time frame: 12 months
Primary Care Visits
Primary Care Visits to Family Physician
Time frame: 12 months
Emergency Department Visits
Emergency Department Visits
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.