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Prehabilitation Program for Head and Neck Cancer

N/A
Waitlist Available
Led By Cheryl Hysjulien, PsyD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Equal to or greater than 18 years of age
Actively pursuing cancer treatment with a curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Awards & highlights

Study Summary

This trial is testing a new way to help people with head and neck cancer that focuses on their quality of life. The current treatment is extremely rigorous and has a profound impact on patients' physical, social, and emotional functioning, often leading to decreased functional capacity and decreased quality of life. The new approach being tested seeks to improve treatment and outcomes by providing personalized education and interventions.

Who is the study for?
This trial is for adults over 18 with a diagnosis of head and neck cancer who are seeking treatment aimed at curing their disease. They must be able to consent to participate. It's not open to those over 375 lbs, with metal allergies, certain heart conditions, pregnant women, or individuals with implanted electronic devices.Check my eligibility
What is being tested?
The study is testing a prehabilitation program designed for patients with head and neck cancer. The program includes personalized education and interventions based on standardized screenings aiming to improve physical, social, and emotional functioning before starting rigorous treatments.See study design
What are the potential side effects?
Since this trial involves educational and supportive interventions rather than drugs or invasive procedures, traditional side effects are not expected. However, participants may experience varying levels of psychological distress due to the nature of the intervention.

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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I am currently seeking treatment to cure my cancer.
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I have been diagnosed with head and neck cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
+2 more
Secondary outcome measures
Change from baseline to after treatment on the 2-min walk test.
Change from baseline to after treatment on the 30 seconds sit to stand.
Change from baseline to after treatment on the BHS-6.
+9 more
Other outcome measures
Behavioral Health Screen
Columbia Suicide Severity Rating Scale
National Comprehensive Cancer Network Distress Thermometer
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Prospective PrehabilitationActive Control1 Intervention
Prospectively enrolling patients into a prehabilitation program for head and neck cancer.
Group II: Prospective ControlActive Control1 Intervention
Prospectively enrolling patients to a control arm with no intervention.

Find a Location

Who is running the clinical trial?

University of North DakotaOTHER
15 Previous Clinical Trials
1,147 Total Patients Enrolled
Sanford HealthLead Sponsor
48 Previous Clinical Trials
61,843 Total Patients Enrolled
Cheryl Hysjulien, PsyDPrincipal InvestigatorSanford Health

Media Library

Prospective Prehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT04617678 — N/A
Head and Neck Cancers Research Study Groups: Prospective Prehabilitation, Prospective Control
Head and Neck Cancers Clinical Trial 2023: Prospective Prehabilitation Highlights & Side Effects. Trial Name: NCT04617678 — N/A
Prospective Prehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04617678 — N/A

Frequently Asked Questions

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

Are medical facilities currently recruiting participants for this trial?

"Affirmative. The information posted on clinicaltrials.gov illustrates that this study is currently recruiting participants, which was initially published on October 21st 2021 and recently modified on November 2nd 2022. 80 volunteers are needed across two different medical sites."

Answered by AI

What aims is this research project seeking to accomplish?

"This clinical trial will track the primary outcome of Study Completion over a period that ranges from Baseline, post-treatment (2 weeks to 6 months), and 6-months follow-up. The secondary outcomes involve determining sarcopenia's impact on functioning with bioimpedence spectroscopy technology (BIS) as well as testing functional assessments such as sit to stand test, grip strength, and two minute walk tests; noting changes in Columbia-Suicide Severity Rating Scale score between baseline and after treatment; measuring variations in Behavioral Health Screening 6 scores pre/post intervention."

Answered by AI

How many individuals are actively engaging in the clinical experimentation?

"Affirmative. The clinical trial database hosted on clinicaltrials.gov illustrates that the study, which was first published on October 21st 2021, is actively searching for participants. A total of 80 patients need to be enrolled from two respective sites."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
~10 spots leftby Aug 2024