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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
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


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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
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : October 15, 2018

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




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



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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

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 Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03215199     History of Changes
Other Study ID Numbers: HREBA.CC-17-0160
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
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