Northern Alberta Psychosocial Telecare (NAPT) Screening f... | NCT03215199

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

NCT03215199

Sponsor

University of Alberta

Status

Terminated

Last Update Posted

May 14, 2026Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Cancer Distress

Interventions

NAPT

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty enrolling participants

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Jul 9, 2017

First Submission Date that Met QC Criteria

Jul 9, 2017

First Posted Date

Jul 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care Group	No Intervention	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.
NAPT Group	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NAPT	Other	Web-based depression and distress monitoring application	NAPT Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distress Thermometer Score	NCCN Distress Thermometer Score	6 months

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G 2B7	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided