NAPT for Cancer Distress

(NAPT Trial)

Overseen By Brittany Barber

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Recurrent cancer, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Eligibility Criteria

This trial is for adults over 18 with new, non-recurrent head and neck cancer who have undergone surgery as their primary treatment. It's not suitable for those under 18, with recurrent cancer, previous chemo or radiation therapy, a history of psychiatric illness or psychological issues, prior cancers or known cancer distress.

Inclusion Criteria

I am 18 years old or older.

My head or neck cancer is new and has not come back.

I have had surgery as my first treatment.

Exclusion Criteria

You have a history of mental health problems.

I have had chemotherapy or radiation therapy before.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments using the NCCN Distress Thermometer Score, QIDS-SR, and HNRN-33

1 week

1 visit (virtual)

Postoperative Monitoring

Participants are monitored using the web-based application at 2 weeks postoperatively and monthly thereafter

12 months

Monthly assessments (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including primary care and emergency visits

12 months

Treatment Details

Interventions

• NAPT

Trial Overview The NAPT study tests a web-based app designed to track depression and stress in patients after head and neck cancer surgery. The goal is to see if it helps in identifying when patients need mental health services. It also looks at how well patients stick to treatments, recover functionally and return to work.

Participant Groups

Group I: NAPT Group Active Control 1 Intervention

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.

Group II: Usual Care Group Active Control 1 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 is already approved in Canada for the following indications:

Approved in Canada as NAPT for:

• Psychosocial screening for head and neck cancer patients

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+