A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Cancer of Head and Neck Clinical Trial

Official title:

A Comprehensive Approach to Head and Neck Cancer Prehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04617678
• Other study ID #: CTR H&N Cancer Prehab
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Other:
• Prehabilitation Program
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.

Locations

Country	Name	City	State
United States	Sanford Health	Fargo	North Dakota
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Sanford Health	University of North Dakota

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Primary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Primary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Primary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Primary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; and 6-months follow-up
Secondary	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.	Baseline; post-treatment, ranging from 2 weeks to 6 months
Secondary	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.	Post-treatment, ranging from 2 weeks to 6 months
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up
Secondary	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).	Baseline; post-treatment, ranging from 2 weeks to 6 months; 6 months follow-up