Clinical trial NCT03215199: Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients
Official title: Northern Alberta Psychosocial Telecare (NAPT) Screening for Surgical Head and Neck Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Distress
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distress Thermometer Score
timeFrame: 6 months
Secondary outcomes:
measure: QIDS Score
timeFrame: 6 and 12 months
measure: HNRN-33
timeFrame: 6 and 12 months
measure: Completion of Adjuvant Therapy
timeFrame: 6 months
measure: Return to work
timeFrame: 12 months
measure: Hospital Readmissions
timeFrame: 12 months
measure: Primary Care Visits
timeFrame: 12 months
measure: Emergency Department Visits
timeFrame: 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: