Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients
NAPT
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2017
CompletedFirst Posted
Study publicly available on registry
July 12, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
August 16, 2024
August 1, 2024
8.8 years
July 9, 2017
August 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Distress Thermometer Score
NCCN Distress Thermometer Score
6 months
Secondary Outcomes (7)
QIDS Score
6 and 12 months
HNRN-33
6 and 12 months
Completion of Adjuvant Therapy
6 months
Return to work
12 months
Hospital Readmissions
12 months
- +2 more secondary outcomes
Study Arms (2)
Usual Care Group
NO INTERVENTIONThe 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 COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- years
- New (non-recurrent) head and neck cancer
- Primary surgical treatment
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2017
First Posted
July 12, 2017
Study Start
September 1, 2017
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share