Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients

Not Applicable

Recruiting

• Conditions: Cancer Distress
• Interventions: Other: NAPT

• Registration Number: NCT03215199
• Lead Sponsor: University of Alberta

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-09
• Study First Posted: 2017-07-12
• Study Start: 2017-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years
• New (non-recurrent) head and neck cancer
• Primary surgical treatment

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAPT Group	NAPT	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.

Primary Outcome Measures

Name	Time	Method
Distress Thermometer Score	6 months	NCCN Distress Thermometer Score

Secondary Outcome Measures

Name	Time	Method
QIDS Score	6 and 12 months	Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
Return to work	12 months	Return to work by 12 months
Hospital Readmissions	12 months	Hospital Readmissions
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
Primary Care Visits	12 months	Primary Care Visits to Family Physician
Emergency Department Visits	12 months	Emergency Department Visits

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada