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Behavioural Intervention

NAPT for Cancer Distress (NAPT Trial)

N/A

Recruiting

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years

New (non-recurrent) head and neck cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

NAPT Trial Summary

This trial is testing a web app to see if it can help manage depression and distress in people who have had surgery for head and neck cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the intervention involves psychosocial screening rather than medication or invasive procedures, typical medical side effects are not expected. However, participants may experience emotional discomfort while discussing personal issues during assessments.

NAPT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

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I have had surgery as my first treatment.

NAPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Distress Thermometer Score

Secondary outcome measures

Completion of Adjuvant Therapy

Emergency Department Visits

HNRN-33

+4 more

NAPT Trial Design

2Treatment groups

Active Control

Group I: NAPT GroupActive Control1 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 GroupActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,084 Total Patients Enrolled

Media Library

NAPT (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03215199 — N/A

Cancer Distress Research Study Groups: NAPT Group, Usual Care Group

Cancer Distress Clinical Trial 2023: NAPT Highlights & Side Effects. Trial Name: NCT03215199 — N/A

NAPT (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03215199 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for participants to join this clinical trial?

"Correct. According to the information present on clinicaltrials.gov, this medical trial is actively accepting patients. It was initially posted in September 1st 2017 and revised lastly on July 11th 2022; 50 individuals are being sought from one centre."

Answered by AI

What is the current enrollment quota for this experiment?

"Affirmative. Data hosted on clinicaltrials.gov provides evidence that this medical experiment, which was first uploaded to the website on September 1st 2017, is actively seeking patients. As of right now, 50 people need to be sourced from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients

2017. "Northern Alberta Psychosocial Telecare (NAPT) Screening for HNC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215199.