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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215199
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Distress Other: NAPT Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 13, 2023
Estimated Study Completion Date : June 13, 2023
Arms and Interventions
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Arm Intervention/treatment
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.
 Other: NAPT
Web-based depression and distress monitoring application


Outcome Measures
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Primary Outcome Measures :
  1. Distress Thermometer Score [ Time Frame: 6 months ]
    NCCN Distress Thermometer Score


Secondary Outcome Measures :
  1. QIDS Score [ Time Frame: 6 and 12 months ]
    Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)

  2. HNRN-33 [ Time Frame: 6 and 12 months ]
    Head and Neck Research Network (HNRN-33)

  3. Completion of Adjuvant Therapy [ Time Frame: 6 months ]
    Completion of Adjuvant Therapy, including radiation or chemotherapy

  4. Return to work [ Time Frame: 12 months ]
    Return to work by 12 months

  5. Hospital Readmissions [ Time Frame: 12 months ]
    Hospital Readmissions

  6. Primary Care Visits [ Time Frame: 12 months ]
    Primary Care Visits to Family Physician

  7. Emergency Department Visits [ Time Frame: 12 months ]
    Emergency Department Visits


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215199


Contacts
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Contact: Brittany Barber 6464459592 brittanybarber0@gmail.com
Contact: Scott Murray sipmurray@gmail.com

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Brittany Barber, MD    16464459592    brittanybarber0@gmail.com   
Contact: Scott Murray, MD       sipmurray@gmail.com   
Sponsors and Collaborators
University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03215199    
Other Study ID Numbers: HREBA.CC-17-0160
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No