Cancer of Head and NeckNCT04617678

A Comprehensive Approach to Head and Neck Cancer Prehabilitation

A study testing Prehabilitation Program in people with Cancer of Head and Neck, run by Sanford Health at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer of Head and Neck
What is being tested?: Prehabilitation Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 2 sitesUnited States
Study dates: 21 Oct 2021to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Equal to or greater than 18 years of age
Diagnosis of head and neck cancer
Actively pursuing cancer treatment with a curative intent
Willing and able to provide written consent

Who cannot join

Patients with cardiac arrhythmia with implanted pacemaker
Patients with other implanted electronic equipment/device
Patients undergoing external defibrillation
Pregnant women (per BIS instructions for use, pregnant women should not participate)
Patient weight exceeding 375 lbs.
Patient has a metal allergy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Sanford Health
Fargo, North Dakota, 58104
Sanford Health
Sioux Falls, South Dakota, 57104

Other trials in United States

About this study

Head and neck cancer accounts for 3% of malignancies in the United States. However, the diagnosis and treatment for head and neck cancer is considered to be debilitating. Not because of its morbidity, but due to the extremely rigorous treatment course which has a profound impact on patients physical, social, and emotional functioning. Disfigurement and sensorimotor deficits further compound this impact. Head and neck cancer patients contend with treatments that can significantly affect their quality of life. Treatment regularly results in decreased functional capacity and decreased quality of life. Physical impairments are manifested through, but not limited to, disfigurement, deconditioning, communication issues, "swallowing, speech, breathing, and cancer-related fatigue". Premorbid factors such as preexisting anxiety and depression, chemical dependency, financial barriers, and lack of social support system are unique obstacles to the head and neck cancer population impacting treatment and outcomes. Due to these factors, patients experience higher rates of anxiety and depression, psychological distress, and fear of cancer recurrence. In fact, "compared with other survivors of cancer, head and neck cancer survivors are almost 2 times more likely to die from suicide". In view of the aforementioned research, Roger Maris Cancer Center's head and neck cancer will implement a prehabilitation program that evaluates each patient using standardized screening tools and provide personalized education and interventions. This project evaluates a more comprehensive and proactive multidisciplinary approach to improve treatment and outcomes in head and neck cancer patients.

Conditions: Cancer of Head and Neck
Being tested: Prehabilitation Program
Medical subject headings: Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prehabilitation ProgramOther
We will assess whether prehabilitation intervention helps mitigate adverse symptoms (e.g., anxiety, depression, suicidality, distress, nutritional status, dysphagia, sarcopenia, and well-being) on a sample of head and neck cancer patients. Subjects will attend a Prepare for Surgery Heal Faster session and meet with a physical therapist, registered dietician, speech language pathologist, and masters of social work at pre-treatment, 6-8 weeks post-treatment, and 5-6 months post-treatment completion.

Study groups in NCT04617678
Study group	Role	What they receive
Prospective Prehabilitation	Active comparator	Prospectively enrolling patients into a prehabilitation program for head and neck cancer. Receives: Other: Prehabilitation Program
Prospective Control	No intervention	Prospectively enrolling patients to a control arm with no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
The Behavioral Health Screening 6 (BHS-6) is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, self-report instrument assessing suicidality. Higher scores indicate greater suicidality. Difference = (Treatment score - Control score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the MDADI to after treatment.
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
The FACT-H\&N (Version 4) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up

Secondary outcomes (12)

Impact of sarcopenia on functioning
Sarcopenia will be measured using bioimpedence spectroscopy technology (BIS), a validated noninvasive measure of volume of fluids in various parts of the body. Functional assessments (sit to stand, grip strength, and two-minute walk test) will be tested as possible predictors of sarcopenia.
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months
Difference between treatment and control group on sarcopenia measures
Sarcopenia measures collected via computed tomography will be used to compare patients who completed the prehabilitation program and those who have not.
Measured: Post-treatment, ranging from 2 weeks to 6 months
Change from baseline to after treatment on the BHS-6.
The Behavioral Health Screening 6 (BHS-6) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the C-SSRS.
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the NCCN Distress Thermometer.
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated self-report measure of psychological health, with higher scores indicating greater psychological distress. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the 2-min walk test.
The 2-min walk test is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the 30 seconds sit to stand.
The 30 seconds sit to stand is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the grip strength.
The grip strength is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the NFPE.
The Nutrition Focused Physical Exam (NFPE) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the MDADI.
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the BIS.
The Bioelectic impedance spectroscopy (BIS) is a validated objective measure of physical functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the FACT-H&N (Version 4).
The FACT-H\&N (Version 4) is a validated, self-report instrument of functional assessments of overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Change = (Post-treatment score - Baseline score).
Measured: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 2021Dec 2026

First posted5 Nov 2020
Study start21 Oct 2021
Primary completion5 Dec 2025
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Parallel groups
Model description: Non-randomized prospective two-arm clinical trial
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04617678
Sponsor's protocol ID: CTR H&N Cancer Prehab
Status last verified: Jan 2026
First submitted: 23 Oct 2020
Last updated: 16 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Samuel SR, Maiya AG, Fernandes DJ, Guddattu V, Saxena PUP, Kurian JR, Lin PJ, Mustian KM. Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy. Support Care Cancer. 2019 Oct;27(10):3913-3920. doi: 10.1007/s00520-019-04750-z. Epub 2019 Mar 27.
PubMed 30919154
Stenson, K. M. (2019). Epidemiology and risk factors for head and neck cancer. UpToDate. Retrieved, November 15, 2019 from https://www.uptodate.com/contents/epidemiology-and-risk-factors-for-head-and-neck-cancer.
Osazuwa-Peters N, Simpson MC, Zhao L, Boakye EA, Olomukoro SI, Deshields T, Loux TM, Varvares MA, Schootman M. Suicide risk among cancer survivors: Head and neck versus other cancers. Cancer. 2018 Oct 15;124(20):4072-4079. doi: 10.1002/cncr.31675. Epub 2018 Oct 18.
PubMed 30335190
Beck ACC, Passchier E, Retel VP, Stuiver MM, van der Molen L, Klop WMC, Navran A, van Harten WH, van den Brekel MWM. Study protocol of a prospective multicenter study comparing (cost-)effectiveness of a tailored interdisciplinary head and neck rehabilitation program to usual supportive care for patients treated with concomitant chemo- or bioradiotherapy. BMC Cancer. 2019 Jul 3;19(1):655. doi: 10.1186/s12885-019-5874-z.
PubMed 31269918
Jung AR, Roh JL, Kim JS, Kim SB, Choi SH, Nam SY, Kim SY. Prognostic value of body composition on recurrence and survival of advanced-stage head and neck cancer. Eur J Cancer. 2019 Jul;116:98-106. doi: 10.1016/j.ejca.2019.05.006. Epub 2019 Jun 10.
PubMed 31185387
Barrett-Bernstein M, Carli F, Gamsa A, Scheede-Bergdahl C, Minnella E, Ramanakumar AV, Tourian L. Depression and functional status in colorectal cancer patients awaiting surgery: Impact of a multimodal prehabilitation program. Health Psychol. 2019 Oct;38(10):900-909. doi: 10.1037/hea0000781. Epub 2019 Aug 5.
PubMed 31380686
Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6.
PubMed 11448365
D'Antonio LL, Zimmerman GJ, Cella DF, Long SA. Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1996 May;122(5):482-7. doi: 10.1001/archotol.1996.01890170018005.
PubMed 8615964
List MA, D'Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E. The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer. 1996 Jun 1;77(11):2294-301. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-S.
PubMed 8635098
Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
PubMed 30193337
Mordarski BA, Hand RK, Wolff J, Steiber AL. Increased Knowledge, Self-Reported Comfort, and Malnutrition Diagnosis and Reimbursement as a Result of the Nutrition-Focused Physical Exam Hands-On Training Workshop. J Acad Nutr Diet. 2017 Nov;117(11):1822-1828. doi: 10.1016/j.jand.2017.06.362. Epub 2017 Aug 16. No abstract available.
PubMed 28821385
Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
PubMed 22193671
Sealy MJ, Dechaphunkul T, van der Schans CP, Krijnen WP, Roodenburg JLN, Walker J, Jager-Wittenaar H, Baracos VE. Low muscle mass is associated with early termination of chemotherapy related to toxicity in patients with head and neck cancer. Clin Nutr. 2020 Feb;39(2):501-509. doi: 10.1016/j.clnu.2019.02.029. Epub 2019 Feb 22.
PubMed 30846324
Wall LR, Ward EC, Cartmill B, Hill AJ. Physiological changes to the swallowing mechanism following (chemo)radiotherapy for head and neck cancer: a systematic review. Dysphagia. 2013 Dec;28(4):481-493. doi: 10.1007/s00455-013-9491-8.
PubMed 24078216

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Head and Neck Cancer (H&N)

All Cancer of Head and Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comprehensive Approach to Head and Neck Cancer Prehabilitation
ClinicalTrials.gov ID: NCT04617678
Acronym / sponsor ID: CTR H&N Cancer Prehab
Conditions: Cancer of Head and Neck
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Sanford HealthUniversity, hospital or other
Collaborators: University of North Dakota
Study start: 21 Oct 2021 (actual)
Primary completion: 5 Dec 2025 (actual)
Study completion: Dec 2026 (estimated)
First posted: 5 Nov 2020 (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.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Non-randomized prospective two-arm clinical trial

Arm	Type	Receives
Prospective Prehabilitation	Active comparator	Other: Prehabilitation ProgramProspectively enrolling patients into a prehabilitation program for head and neck cancer.
Prospective Control	No intervention	–Prospectively enrolling patients to a control arm with no intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Equal to or greater than 18 years of age
Diagnosis of head and neck cancer
Actively pursuing cancer treatment with a curative intent
Willing and able to provide written consent

Key exclusion criteria (6 listed)

Patients with cardiac arrhythmia with implanted pacemaker
Patients with other implanted electronic equipment/device
Patients undergoing external defibrillation
Pregnant women (per BIS instructions for use, pregnant women should not participate)
Patient weight exceeding 375 lbs.

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
Prehabilitation ProgramWe will assess whether prehabilitation intervention helps mitigate adverse symptoms (e.g., anxiety, depression, suicidality, distress, nutritional status, dysphagia, sarcopenia, and well-being) on a sample of head and neck cancer patients. Subjects will attend a Prepare for Surgery Heal Faster session and meet with a physical therapist, registered dietician, speech language pathologist, and masters of social work at pre-treatment, 6-8 weeks post-treatment, and 5-6 months post-treatment completion.	Other	Prospective Prehabilitation

Primary outcome

Difference between treatment and control group, from baseline in the BHS-6 to after treatment.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The Behavioral Health Screening 6 (BHS-6) is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the C-SSRS to after treatment.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, self-report instrument assessing suicidality. Higher scores indicate greater suicidality. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the NCCN Distress Thermometer after treatment.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The National Comprehensive Cancer Network (NCCN) Distress Thermometer is a validated, self-report instrument assessing psychological health. Higher scores indicate greater psychological distress. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the MDADI to after treatment.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The MD Anderson Dysphagia Inventory (MDADI) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).
Difference between treatment and control group, from baseline in the FACT-H&N (Version 4) to after treatment.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
The FACT-H\&N (Version 4) is a validated, self-report instrument of functional assessments of dysphasia and overall functioning. Higher scores indicate better quality of life and higher day-to-day functioning. Difference = (Treatment score - Control score).

12 secondary outcomes

Impact of sarcopenia on functioning
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months
Difference between treatment and control group on sarcopenia measures
Time frame: Post-treatment, ranging from 2 weeks to 6 months
Change from baseline to after treatment on the BHS-6.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the C-SSRS.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the NCCN Distress Thermometer.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the 2-min walk test.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the 30 seconds sit to stand.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the grip strength.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the NFPE.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the MDADI.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the BIS.
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Change from baseline to after treatment on the FACT-H&N (Version 4).
Time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Background: PubMed 30919154Samuel SR, Maiya AG, Fernandes DJ, Guddattu V, Saxena PUP, Kurian JR, Lin PJ, Mustian KM. Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy. Support Care Cancer. 2019 Oct;27(10):3913-3920. doi: 10.1007/s00520-019-04750-z. Epub 2019 Mar 27.
BackgroundStenson, K. M. (2019). Epidemiology and risk factors for head and neck cancer. UpToDate. Retrieved, November 15, 2019 from https://www.uptodate.com/contents/epidemiology-and-risk-factors-for-head-and-neck-cancer.
Background: PubMed 30335190Osazuwa-Peters N, Simpson MC, Zhao L, Boakye EA, Olomukoro SI, Deshields T, Loux TM, Varvares MA, Schootman M. Suicide risk among cancer survivors: Head and neck versus other cancers. Cancer. 2018 Oct 15;124(20):4072-4079. doi: 10.1002/cncr.31675. Epub 2018 Oct 18.
Background: PubMed 31269918Beck ACC, Passchier E, Retel VP, Stuiver MM, van der Molen L, Klop WMC, Navran A, van Harten WH, van den Brekel MWM. Study protocol of a prospective multicenter study comparing (cost-)effectiveness of a tailored interdisciplinary head and neck rehabilitation program to usual supportive care for patients treated with concomitant chemo- or bioradiotherapy. BMC Cancer. 2019 Jul 3;19(1):655. doi: 10.1186/s12885-019-5874-z.
Background: PubMed 31185387Jung AR, Roh JL, Kim JS, Kim SB, Choi SH, Nam SY, Kim SY. Prognostic value of body composition on recurrence and survival of advanced-stage head and neck cancer. Eur J Cancer. 2019 Jul;116:98-106. doi: 10.1016/j.ejca.2019.05.006. Epub 2019 Jun 10.
Background: PubMed 31380686Barrett-Bernstein M, Carli F, Gamsa A, Scheede-Bergdahl C, Minnella E, Ramanakumar AV, Tourian L. Depression and functional status in colorectal cancer patients awaiting surgery: Impact of a multimodal prehabilitation program. Health Psychol. 2019 Oct;38(10):900-909. doi: 10.1037/hea0000781. Epub 2019 Aug 5.
Background: PubMed 11448365Chen AY, Frankowski R, Bishop-Leone J, Hebert T, Leyk S, Lewin J, Goepfert H. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M. D. Anderson dysphagia inventory. Arch Otolaryngol Head Neck Surg. 2001 Jul;127(7):870-6.
Background: PubMed 8615964D'Antonio LL, Zimmerman GJ, Cella DF, Long SA. Quality of life and functional status measures in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 1996 May;122(5):482-7. doi: 10.1001/archotol.1996.01890170018005.
Background: PubMed 8635098List MA, D'Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E. The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer. 1996 Jun 1;77(11):2294-301. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-S.
Background: PubMed 30193337Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
Background: PubMed 28821385Mordarski BA, Hand RK, Wolff J, Steiber AL. Increased Knowledge, Self-Reported Comfort, and Malnutrition Diagnosis and Reimbursement as a Result of the Nutrition-Focused Physical Exam Hands-On Training Workshop. J Acad Nutr Diet. 2017 Nov;117(11):1822-1828. doi: 10.1016/j.jand.2017.06.362. Epub 2017 Aug 16. No abstract available.
Background: PubMed 22193671Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

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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.

Cheryl Hysjulien, PsyD principal investigator

Sanford Health

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation Program in people with Cancer of Head and Neck, run by Sanford Health at 2 sites in United States.

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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

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?

Difference between treatment and control group, from baseline in the BHS-6 to after treatment. (time frame: Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617678, which also lists 14 linked publications.

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 16 Jan 2026.