NCT03215199

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

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

July 9, 2017

Last Update Submit

May 11, 2026

Conditions

Cancer Distress

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 INTERVENTION

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.

NAPT Group

ACTIVE COMPARATOR

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

Interventions

NAPTOTHER

Web-based depression and distress monitoring application

NAPT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

June 30, 2020

Study Completion

June 30, 2020

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)