Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients
NCT ID: NCT03215199
Last Updated: 2024-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2017-09-01
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
NAPT
Web-based depression and distress monitoring application
Interventions
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NAPT
Web-based depression and distress monitoring application
Eligibility Criteria
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Inclusion Criteria
* New (non-recurrent) head and neck cancer
* Primary surgical treatment
Exclusion Criteria
* Recurrent head and neck cancer
* Previous chemotherapy or radiation therapy
* History of psychiatric or psychologic illness
* History of previous cancers or cancer distress
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Locations
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University of Alberta
Edmonton, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HREBA.CC-17-0160
Identifier Type: -
Identifier Source: org_study_id
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