Cancer DistressNAPTNCT03215199
Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients
A study testing NAPT in people with Cancer Distress, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Distress
- What is being tested?
- NAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years
- New (non-recurrent) head and neck cancer
- Primary surgical treatment
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Northern Alberta Psychosocial Telecare (NAPT) Screening for Surgical Head and Neck Cancer Patients: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cancer Distress
- Being tested
- NAPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAPTOther
Web-based depression and distress monitoring application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress Thermometer Score
NCCN Distress Thermometer Score
Measured: 6 months
Secondary outcomes (7)
QIDS Score
Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR)
Measured: 6 and 12 months
HNRN-33
Head and Neck Research Network (HNRN-33)
Measured: 6 and 12 months
Completion of Adjuvant Therapy
Completion of Adjuvant Therapy, including radiation or chemotherapy
Measured: 6 months
Return to work
Return to work by 12 months
Measured: 12 months
Hospital Readmissions
Hospital Readmissions
Measured: 12 months
Primary Care Visits
Primary Care Visits to Family Physician
Measured: 12 months
Emergency Department Visits
Emergency Department Visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Sep 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Difficulty enrolling participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer DistressStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215199
- Sponsor's protocol ID
- HREBA.CC-17-0160
- Acronym
- NAPT
- Status last verified
- May 2026
- First submitted
- 9 Jul 2017
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Alberta Psychosocial Telecare (NAPT) Screening for Surgical Head and Neck Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03215199
- Acronym / sponsor ID
- NAPT / HREBA.CC-17-0160
- Conditions
- Cancer Distress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling participants
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: NAPTThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years
- New (non-recurrent) head and neck cancer
- Primary surgical treatment
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAPTWeb-based depression and distress monitoring application | Other | NAPT Group |
Primary outcome
Distress Thermometer Score
Time frame: 6 months
NCCN Distress Thermometer Score
7 secondary outcomes
QIDS Score
Time frame: 6 and 12 months
HNRN-33
Time frame: 6 and 12 months
Completion of Adjuvant Therapy
Time frame: 6 months
Return to work
Time frame: 12 months
Hospital Readmissions
Time frame: 12 months
Primary Care Visits
Time frame: 12 months
Emergency Department Visits
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulty enrolling participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAPT in people with Cancer Distress, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty enrolling participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress Thermometer Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.