Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients (NAPT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Cancer Distress
• Intervention / Treatment: Other: NAPT

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group; 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; 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; Web-based depression and distress monitoring application

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HREBA.CC-17-0160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No