Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients

Cancer Distress Clinical Trial

— NAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215199
• Other study ID #: HREBA.CC-17-0160
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: June 13, 2024

Study information

• Verified date: July 2023
• Source: University of Alberta
• Contact: Brittany Barber
• Phone: 6464459592
• Email: brittanybarber0[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 /=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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 13, 2024
• Est. primary completion date: June 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Distress

Intervention

Other:
• NAPT
Web-based depression and distress monitoring application

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress Thermometer Score	NCCN Distress Thermometer Score	6 months
Secondary	QIDS Score	Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)	6 and 12 months
Secondary	HNRN-33	Head and Neck Research Network (HNRN-33)	6 and 12 months
Secondary	Completion of Adjuvant Therapy	Completion of Adjuvant Therapy, including radiation or chemotherapy	6 months
Secondary	Return to work	Return to work by 12 months	12 months
Secondary	Hospital Readmissions	Hospital Readmissions	12 months
Secondary	Primary Care Visits	Primary Care Visits to Family Physician	12 months
Secondary	Emergency Department Visits	Emergency Department Visits	12 months