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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a web-based tool called NAPT, designed to assist individuals who have undergone surgery for head and neck cancer. The tool monitors feelings of depression and distress and connects patients to mental health professionals if needed. Participants use the app to track their mood and involve caregivers for support. This trial suits those newly diagnosed with head and neck cancer and undergoing their first surgical treatment. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance mental health support for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that the NAPT Screening Application is safe for monitoring depression and distress in cancer patients?

Research has shown that using a web-based tool to track mood and distress in cancer patients is safe and helpful. In one study, patients used an app to monitor their health during cancer treatment, finding it easy to use and beneficial for managing emotions.

Another study found that patients using a similar app to track distress experienced improved mood and quality of life over time, with no serious negative effects.

Overall, these findings suggest the app is well-tolerated and can support emotional health without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NAPT for cancer distress because it offers a new way to actively monitor and manage the emotional well-being of patients with head and neck cancer. Unlike standard treatments that focus primarily on physical symptoms, NAPT uses a web-based application to track depression and distress levels, allowing for real-time alerts and interventions. This approach not only empowers patients to be more engaged in their care but also involves caregivers, potentially improving overall treatment outcomes by addressing both emotional and functional issues more promptly.

What evidence suggests that the NAPT Screening Application is effective for monitoring depression and distress in head and neck cancer patients?

Research has shown that using technology to track distress and depression in cancer patients can help reduce emotional problems. After implementing a distress screening system, patients reported fewer practical, social, and emotional issues. Another study found that participating in a support program improved patients' quality of life and reduced distress over 18 months. In this trial, participants in the NAPT Group will use the NAPT web-based application to monitor and manage distress in patients with head and neck cancer effectively. The application allows patients to track their mood and alerts their medical team if support is needed. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-8-2017-77fce

NAPT for Cancer Distress (NAPT Trial) Patients will be given access to a web-based application that monitors depression, distress, and functional outcomes scores at regular intervals for 12 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7256091/

Effects on patient-reported outcomes of “Screening of Distress ... After implementation of SDRN, patients report significantly fewer psychosocial (practical, social, and emotional) problems on the DT/PL.

3. bmjopen.bmj.com bmjopen.bmj.com/content/11/3/e041878

Technology-assisted depression screening tools for ... This systematic review addresses the use of technology for depression screening in patients with cancer, as well as the process evaluation (feasibility, ...

4. jons-online.com jons-online.com/issues/2020/october-2020-vol-11-no-10/3148-patient-navigation-effect-on-cancer-patients-quality-of-life-and-distress

Patient Navigation Effect on Cancer Patients' Quality of Life ... This investigation found that distress and QOL improved over a period of 18 months while patients were in a navigation program after a diagnosis of cancer.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1098360023009966

Systematic evidence review and meta-analysis of ... For patient-reported outcomes, pre-test GC significantly decreased worry, increased knowledge, and decreased perceived risk but did not significantly affect ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10623226/

App-Controlled Treatment Monitoring and Support for Patients ... App-controlled treatment monitoring and support for patients with head and neck cancer undergoing radiotherapy: results from a prospective randomized ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9221700/

Screening for Distress and Health Outcomes in Head ... This paper compares the prevalence of emotional distress in HNC across various distress screening measures and examines whether significant distress or ...

8. hca.wa.gov hca.wa.gov/assets/program/1-pbt-drft-rpt-peer-review-response-complete-20190425.pdf

Proton Beam Therapy – Re-review Acute toxicity in comprehensive head and neck radiation for nasopharynx and paranasal sinus cancers: cohort comparison of 3D conformal proton ...

9. researchgate.net researchgate.net/publication/376993040_Temporal_Evolution_and_Diagnostic_Diversification_of_Patients_Receiving_Proton_Therapy_in_the_United_States_A_Ten-Year_Trend_Analysis_2012-21_from_the_National_Association_for_Proton_Therapy

A Ten-Year Trend Analysis (2012-21) from the National ... This data is consistent with 10-year survey data (2012-2021) from the National Association for Proton Therapy (NAPT), which showed a 15.6-fold ...