Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients (NAPT)
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|ClinicalTrials.gov Identifier: NCT03215199|
Recruitment Status : Unknown
Verified July 2017 by University of Alberta.
Recruitment status was: Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Distress||Other: NAPT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Northern Alberta Psychosocial Telecare (NAPT) Screening for Surgical Head and Neck Cancer Patients: a Randomized Controlled Trial|
|Estimated Study Start Date :||September 2017|
|Estimated Primary Completion Date :||September 15, 2018|
|Estimated Study Completion Date :||October 15, 2018|
No Intervention: 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.
Active Comparator: 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.
Web-based depression and distress monitoring application
- Distress Thermometer Score [ Time Frame: 6 months ]NCCN Distress Thermometer Score
- QIDS Score [ Time Frame: 6 and 12 months ]Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
- HNRN-33 [ Time Frame: 6 and 12 months ]Head and Neck Research Network (HNRN-33)
- Completion of Adjuvant Therapy [ Time Frame: 6 months ]Completion of Adjuvant Therapy, including radiation or chemotherapy
- Return to work [ Time Frame: 12 months ]Return to work by 12 months
- Hospital Readmissions [ Time Frame: 12 months ]Hospital Readmissions
- Primary Care Visits [ Time Frame: 12 months ]Primary Care Visits to Family Physician
- Emergency Department Visits [ Time Frame: 12 months ]Emergency Department Visits
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215199
|Contact: Brittany Barberemail@example.com|
|Contact: Scott Murrayfirstname.lastname@example.org|
|University of Alberta||Active, not recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|