Cancer Distress
Conditions
Brief summary
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
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.
Interventions
OTHERNAPT
Web-based depression and distress monitoring application
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distress Thermometer Score | 6 months | NCCN Distress Thermometer Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QIDS Score | 6 and 12 months | Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) |
| HNRN-33 | 6 and 12 months | Head and Neck Research Network (HNRN-33) |
| Completion of Adjuvant Therapy | 6 months | Completion of Adjuvant Therapy, including radiation or chemotherapy |
| Return to work | 12 months | Return to work by 12 months |
| Hospital Readmissions | 12 months | Hospital Readmissions |
| Primary Care Visits | 12 months | Primary Care Visits to Family Physician |
| Emergency Department Visits | 12 months | Emergency Department Visits |
Countries
Canada
Outcome results
None listed