A PILOT RANDOMIZED CONTROLLED TRIAL TO ASSESS FEASIBILITY, SYMPTOMS, AND BIO

BEHAVIORAL OUTCOMES OF ACUPUNCTURE IN PATIENTS UNDERGOING RADIATION THERAPY FOR SQUAMOUS CELL CARCINOMA OF THE HEAD AND

NECK

INVESTIGATORS

Principal Investigator:Suzanne Monahan, RN, BSN, STAR/TCancer Care Coordinator

Allina Co-Investigators: Sue Sendelbach, PhD, RN, APRN, CNS, FAHA, FAANDirector of Nursing Research

Jeff Dusek, PhDDirector of PGIHH Research

St. Catherine’s Co-Investigators:Alvina Brueggemann, PhDCynthia Lee Dols Finn, MN, RN, CNE, PHNBrenda Lee Frie MA, OTR/L, CHTDorothea B. Hansmeyer, MA, RN, CNE, PHNMelissa Lam, OT StudentTamara Nascene, OT StudentLaurie A. Sieve, DNP, RN, PHN

HEAD & NECK CANCER• Any malignancy (cancer) originating in the

head and neck region, including the nasal cavity, sinuses, oral cavity, salivary glands, larynx, and pharynx

• Over 90% of head & neck malignancies (cancer) are of squamous cell origin; involving the cells that make up the mucosal lining of the head and neck region (Walden & Aygun, 2013)

• Approximately 70% of oral cancers are linked to HPV (http://www.cdc.gov/cancer/hpv/statistics/headneck.htm)

• Patients with head and neck cancer demonstrate significant levels of anxiety, depression, pain, distress, and difficulty coping (Dripkin, 2001; Hammerlid et al., 1999; Kugaya et al., 2000).  

• Distress, if unmanaged, can lead to a patient’s reduced chance of survival (Carlson, 2013), decreased satisfaction with care, poorer adherence to treatment recommendations, and reduced quality of life (Waller, 2013).

ACUPUNCTURE

• Integrative Medicine treatments, such as acupuncture, have been shown to reduce anxiety, pain, depression, improve sleep, and increase quality of life in a variety of cancer patients (Chiu et al., 2016; Dean-Clower et al., 2010; Mehling et al., 2007; Feng et al., 2011)

• Despite the recognition that patients with head and neck cancer experience a great amount of distress (Dropkin, 2001), there are very few published studies that examine interventions to address psychological health in this population

“Acupuncture helped with my claustrophobia; it also taught me how to relax when I needed it at home or when I went on the radiation table” – Karl C. (previous patient who used acupuncture throughout his head and neck cancer treatment, 2016)

STUDY AIM

Primary Aim:Aim 1: Examine the feasibility of an acupuncture regimen to patients undergoing a radiation therapy program for squamous cell carcinoma of the head and neck.Secondary Aims:Aim 1: Determine the difference, if any, in the level of anxiety in patients receiving acupuncture compared to the usual care group during and following radiation treatment courseAim 2: Determine the difference, if any, in the level of depression, pain, sleep, fatigue, physical health, satisfaction of social role, patient perception of stress and quality of life (QOL) in patients receiving acupuncture compared to the usual care group during and following radiation treatment courseAim 3: Examine the associations between psychological outcomes (depression, pain, sleep, fatigue, physical health, satisfaction of social role, patient perception of stress and quality of life (QOL), and/or the associations between demographic variables (age, gender, acupuncture experiences, etc.)

METHOD

Study DesignThis pilot study will be a randomized controlled trial of 24 patients receiving usual care and 24 patients receiving the acupuncture intervention.

SampleMale/Female18 years or olderSquamous Cell Carcinoma of the head and neck Radiation therapy

TIMELINE OF DATA COLLECTIONBaseline Week 4 Week 7 Week 10 Week 13

PROMIS-57 X X X X X

FACT-OHN X X X X X

PSS-10 X X X X X

Timeline for Project:

DATA COLLECTION TOOLS SUMMARYPROMIS-57

A self-rated assessment of symptoms and function4 questions on each of the seven domains: Depression, Anxiety, Physical Function, Pain Inference, Fatigue, Sleep Disturbance and Ability to Participate is Social RolesProvides information on both physical and mental health, according to the patientDesigned for adults over the age of 18

DATA COLLECTION TOOLS SUMMARYFACIT – H&NFunctional Assessment of Cancer Therapy – Head & Neck Scale (FACIT-H&N)Questions specific about type of cancer

i.e. My voice has usual quality and strength; I can eat solid foodsMeasures quality of life in head and neck patientsFive subscales: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns

DATA COLLECTION TOOLSPERCEIVED STRESS SCALE (PSS)

Measures “the degree to which situations in one’s life are appraised as stressful” (Cohen, Kamarch, & Mermelstein, 1983, p. 385)

Generalized questionsi.e. In the last month, how often have you felt nervous or

stressed?

THANK YOU

Abbott Northwestern Hospital Foundation for providing the grant to make this research project possible!

REFERENCES

Carlson, L.E., Waller, A., Groff, S.L., Giese-Davis, J., & Bultz, B.D.  (2013). What goes up does not always come down: Patterns of distress, physical and psychosocial morbidity in people with cancer over a one year period. Psycho-Oncology, 22, 168-176. doi:10.1002/pon.2068Chiu, H. Y., Hsieh, Y. J., & Tsai, P. S. (2016). Systematic review and meta-analysis of acupuncture to reduce cancer-related pain. European Journal of Cancer Care. doi:10.1111/ecc.12457Dean-Clower, E., Doherty-Gilman, A.M., Keshaviah, A., Baker, F., Kaw, C., Lu, W., Rosenthal, D.S. (2010). Acupuncture as palliative therapy for physical symptoms and quality of life for advanced cancer patients. Integrative Cancer Therapies, 9(2), 158-167. doi:10.1177/1534735409360666

Dropkin, M.J. (2001). Anxiety, coping strategies and coping behaviors in patients undergoing head and neck cancer surgery. Cancer Nursing, 24(2), 143-148. doi: 10.1097/00002820-200104000-00010Feng, Y., Wang, X., Li, S., Zhang, Y., Wang, H., Li, M., . . . Zhang, Z. (2011). Clinical research of acupuncture on malignant tumor patients for improving depression and sleep quality. Journal of Traditional Chinese Medicine, 31(3), 199-202. doi:10.1016/S0254-6272(11)60042-3

Hammerlid, E., Ahlner-Elmqvist, M., Bjordal, K., Biorklund, A., Evenson, J., Boysen, M., . . . Westin, T. (1999). A prospective muticentre study in Sweden and Norway of mental distress and psychiatric morbidity in head and neck cancer patients. British Journal of Cancer, 80(5/6), 766-774. doi:10.1038/sj.bjc.6690420Kugaya, A., Akechi, T., Toru, O., Nakano, T., Mikami, I., Okamura. H. & Uchitomi, Y. (2000).Prevalence, predictive factors, and screening for psychologic distress in patients with newly diagnosed head and neck cancer. Cancer, 88(12), 2817-2923. doi:10.1016/j.hoc.2008.04.005

Mehling, W.E., Jacobs, B., Acree, M., Wilson, L., Bostrom, A., West, J., . . . Hecht, F.M. (2007). Symptom management with massage and acupuncture in postoperative cancer patients:  A randomized controlled trial. Journal of Pain and Symptom Management, 33(3), 258-266. doi: 10.1016/j.jpainsymman.2006.09.016

Walden, M.J., & Aygun, N. (2013). Head and neck cancer. Seminars in Roentgenology, 48, 75- 86. doi: 10.1053/j.ro.2012.09.002

Waller, A., Williams, A., Groff, S.L., Bultz, B.D., & Carlson, L.E. (2013). Screening for distress, the sixth vital sign: Examining self-referral in people with cancer over a one-year period.Psycho-Oncology, 22, 388-395. doi: 10.1002/pon.2102