Clinical trial NCT02063828: Reducing Lung Cancer-Related Anxiety (RELAX)
Official title: Reducing Lung Cancer-Related Anxiety (RELAX)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Keywords: anxiety
Dyspnea
respiratory functioning
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-02-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to compare the effects of music and different levels of device-guided breathing on anxiety and shortness of breath in lung cancer survivors.

Detailed description: OBJECTIVES

1. To assess feasibility (accrual, participation, adherence, retention) of a randomized study of device-guided breathing and music in 75 post-treatment lung cancer survivors with significant anxiety.
2. To obtain preliminary data on the variability and efficacy of two doses of a device-guided breathing intervention versus a music control group for reducing anxiety (primary outcome) and for improving self-reported dyspnea and respiratory functioning (secondary outcomes) in post-treatment lung cancer survivors.
3. To select the optimal dose of the device-guided breathing intervention (15 minutes once/day or twice/day) for subsequent randomized study.

Eligibility criteria: Inclusion Criteria:

* Past History of any lung cancer
* For Stage I-III disease, patients should be 2-24 months post-completion of surgery, radiation therapy and/or chemotherapy with no further planned treatment during the 12-week study and no evidence of disease.
* For Stage IV disease, patients may be receiving no treatment or may be receiving maintenance treatment with a target agent, chemotherapy, or immunotherapy provided the most recent imaging does not demonstrate progressive disease.
* After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible.
* Willing/able to attend brief introductory session and use assigned device for the assigned period of time (15 minutes once or twice per day), at least 5 days per week for 12 weeks
* Age ≥ 18 years
* Must have telephone

Exclusion Criteria:

* Patient does not understand English
* Active lung infection
* Progressive cancer (must be considered no evidence of disease or stable)
* Any change in psychotropic medications in past 30 days
* Hearing loss that would preclude participating in interventions. Adequate hearing to participate will be determined via: (1) Response of "no" to the question \["Do you have a hearing problem now?"\] Participants with hearing aids will be allowed to enroll as long as their hearing is adequate to hear the sounds on the study devices. If necessary, potential study participants will receive a brief test trial with the RESPeRATE device. If they indicate inability to hear the guiding tones, they will not be enrolled in the study.

Cortisol Exclusion

- Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted).

Primary outcomes:
measure: Retention - Number of Participants Who Complete the Final Assessment
timeFrame: 12 weeks
measure: Adherence- Amount of Time the Device is Used
timeFrame: 12 weeks
measure: Accrual Rate- Number of Patients Accrued to the Study
timeFrame: Time from study opening to study close ~46.42 months
Secondary outcomes:
measure: Change From Baseline for Anxiety as Measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
Other outcomes:
measure: Salivary Cortisol Levels
timeFrame: 12 weeks
measure: DNA Methylation Levels
timeFrame: 12 weeks
measure: Gene Expression Levels
timeFrame: 12 weeks
Locations:
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: Wichita
country: United States
facility: Cancer Center of Kansas-Wichita Medical Arts Tower
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas - Wichita
state: Kansas
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Hendersonville
country: United States
facility: Margaret R Pardee Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne C Danhauer, PhD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Glenn Lesser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pal GK, Velkumary S, Madanmohan. Effect of short-term practice of breathing exercises on autonomic functions in normal human volunteers. Indian J Med Res. 2004 Aug;120(2):115-21.
citation: National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
citation: Bach PB, Mirkin JN, Oliver TK, Azzoli CG, Berry DA, Brawley OW, Byers T, Colditz GA, Gould MK, Jett JR, Sabichi AL, Smith-Bindman R, Wood DE, Qaseem A, Detterbeck FC. Benefits and harms of CT screening for lung cancer: a systematic review. JAMA. 2012 Jun 13;307(22):2418-29. doi: 10.1001/jama.2012.5521.
citation: Wender R, Fontham ET, Barrera E Jr, Colditz GA, Church TR, Ettinger DS, Etzioni R, Flowers CR, Gazelle GS, Kelsey DK, LaMonte SJ, Michaelson JS, Oeffinger KC, Shih YC, Sullivan DC, Travis W, Walter L, Wolf AM, Brawley OW, Smith RA. American Cancer Society lung cancer screening guidelines. CA Cancer J Clin. 2013 Mar-Apr;63(2):107-17. doi: 10.3322/caac.21172. Epub 2013 Jan 11.
citation: Doria-Rose VP, White MC, Klabunde CN, Nadel MR, Richards TB, McNeel TS, Rodriguez JL, Marcus PM. Use of lung cancer screening tests in the United States: results from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Jul;21(7):1049-59. doi: 10.1158/1055-9965.EPI-12-0343. Epub 2012 May 9.
citation: Alfano CM, Rowland JH. Recovery issues in cancer survivorship: a new challenge for supportive care. Cancer J. 2006 Sep-Oct;12(5):432-43. doi: 10.1097/00130404-200609000-00012.
citation: Hodgkinson K, Butow P, Fuchs A, Hunt GE, Stenlake A, Hobbs KM, Brand A, Wain G. Long-term survival from gynecologic cancer: psychosocial outcomes, supportive care needs and positive outcomes. Gynecol Oncol. 2007 Feb;104(2):381-9. doi: 10.1016/j.ygyno.2006.08.036. Epub 2006 Oct 5.
citation: Jacobsen PB DKSZetal. Management of anxiety and depression in adult cancer patients: Toward an evidence-based approach. In: Chang AE GPHDea, editor. Oncology: An Evidence-Based Approach. Philadelphia, PA: Springer; 2006. p. 1552-79.
citation: Jefford M, Karahalios E, Pollard A, Baravelli C, Carey M, Franklin J, Aranda S, Schofield P. Survivorship issues following treatment completion--results from focus groups with Australian cancer survivors and health professionals. J Cancer Surviv. 2008 Mar;2(1):20-32. doi: 10.1007/s11764-008-0043-4. Epub 2008 Jan 25.
citation: Stanton AL, Bower JE, Low CA. Posttraumatic Growth After Cancer. In 2006. p. 138-75.
citation: Brintzenhofe-Szoc KM, Levin TT, Li Y, Kissane DW, Zabora JR. Mixed anxiety/depression symptoms in a large cancer cohort: prevalence by cancer type. Psychosomatics. 2009 Jul-Aug;50(4):383-91. doi: 10.1176/appi.psy.50.4.383.
citation: Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6.
citation: Li J, Girgis A. Supportive care needs: are patients with lung cancer a neglected population? Psychooncology. 2006 Jun;15(6):509-16. doi: 10.1002/pon.983.
citation: Baker F, Denniston M, Smith T, West MM. Adult cancer survivors: how are they faring? Cancer. 2005 Dec 1;104(11 Suppl):2565-76. doi: 10.1002/cncr.21488.
citation: Uchitomi Y, Mikami I, Nagai K, Nishiwaki Y, Akechi T, Okamura H. Depression and psychological distress in patients during the year after curative resection of non-small-cell lung cancer. J Clin Oncol. 2003 Jan 1;21(1):69-77. doi: 10.1200/JCO.2003.12.139.
citation: Ostroff JS, Krebs P, Coups EJ, Burkhalter JE, Feinstein MB, Steingart RM, Logue AE, Park BJ. Health-related quality of life among early-stage, non-small cell, lung cancer survivors. Lung Cancer. 2011 Jan;71(1):103-8. doi: 10.1016/j.lungcan.2010.04.011. Epub 2010 May 11.
citation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
citation: Hung R, Krebs P, Coups EJ, Feinstein MB, Park BJ, Burkhalter J, Ostroff JS. Fatigue and functional impairment in early-stage non-small cell lung cancer survivors. J Pain Symptom Manage. 2011 Feb;41(2):426-35. doi: 10.1016/j.jpainsymman.2010.05.017. Epub 2011 Jan 8.
citation: Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: prevalence rates by cancer type, gender, and age. J Affect Disord. 2012 Dec 10;141(2-3):343-51. doi: 10.1016/j.jad.2012.03.025. Epub 2012 Jun 21.
citation: Smith EL, Hann DM, Ahles TA, Furstenberg CT, Mitchell TA, Meyer L, Maurer LH, Rigas J, Hammond S. Dyspnea, anxiety, body consciousness, and quality of life in patients with lung cancer. J Pain Symptom Manage. 2001 Apr;21(4):323-9. doi: 10.1016/s0885-3924(01)00255-x.
citation: Tanaka K, Akechi T, Okuyama T, Nishiwaki Y, Uchitomi Y. Prevalence and screening of dyspnea interfering with daily life activities in ambulatory patients with advanced lung cancer. J Pain Symptom Manage. 2002 Jun;23(6):484-9. doi: 10.1016/s0885-3924(02)00394-9.
citation: Dudgeon DJ, Lertzman M, Askew GR. Physiological changes and clinical correlations of dyspnea in cancer outpatients. J Pain Symptom Manage. 2001 May;21(5):373-9. doi: 10.1016/s0885-3924(01)00278-0.
citation: Henoch I, Bergman B, Danielson E. Dyspnea experience and management strategies in patients with lung cancer. Psychooncology. 2008 Jul;17(7):709-15. doi: 10.1002/pon.1304.
citation: Ryan LS. Psychosocial issues and lung cancer: a behavioral approach. Semin Oncol Nurs. 1996 Nov;12(4):318-23. doi: 10.1016/s0749-2081(96)80031-3.
citation: Hopwood P, Stephens RJ. Symptoms at presentation for treatment in patients with lung cancer: implications for the evaluation of palliative treatment. The Medical Research Council (MRC) Lung Cancer Working Party. Br J Cancer. 1995 Mar;71(3):633-6. doi: 10.1038/bjc.1995.124.
citation: Muers MF, Round CE. Palliation of symptoms in non-small cell lung cancer: a study by the Yorkshire Regional Cancer Organisation Thoracic Group. Thorax. 1993 Apr;48(4):339-43. doi: 10.1136/thx.48.4.339.
citation: Reuben DB, Mor V. Dyspnea in terminally ill cancer patients. Chest. 1986 Feb;89(2):234-6. doi: 10.1378/chest.89.2.234.
citation: Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
citation: Feinstein MB, Krebs P, Coups EJ, Park BJ, Steingart RM, Burkhalter J, Logue A, Ostroff JS. Current dyspnea among long-term survivors of early-stage non-small cell lung cancer. J Thorac Oncol. 2010 Aug;5(8):1221-6. doi: 10.1097/JTO.0b013e3181df61c8.
citation: Tishelman C, Degner LF, Rudman A, Bertilsson K, Bond R, Broberger E, Doukkali E, Levealahti H. Symptoms in patients with lung carcinoma: distinguishing distress from intensity. Cancer. 2005 Nov 1;104(9):2013-21. doi: 10.1002/cncr.21398.
citation: Tanaka K, Akechi T, Okuyama T, Nishiwaki Y, Uchitomi Y. Factors correlated with dyspnea in advanced lung cancer patients: organic causes and what else? J Pain Symptom Manage. 2002 Jun;23(6):490-500. doi: 10.1016/s0885-3924(02)00400-1.
citation: O'Driscoll M, Corner J, Bailey C. The experience of breathlessness in lung cancer. Eur J Cancer Care (Engl). 1999 Mar;8(1):37-43. doi: 10.1046/j.1365-2354.1999.00129.x.
citation: Gupta D, Lis CG, Grutsch JF. The relationship between dyspnea and patient satisfaction with quality of life in advanced cancer. Support Care Cancer. 2007 May;15(5):533-8. doi: 10.1007/s00520-006-0178-7. Epub 2006 Nov 21.
citation: Wilhelm FH, Gevirtz R, Roth WT. Respiratory dysregulation in anxiety, functional cardiac, and pain disorders. Assessment, phenomenology, and treatment. Behav Modif. 2001 Sep;25(4):513-45. doi: 10.1177/0145445501254003.
citation: Clark ME, Hirschman R. Effects of paced respiration on anxiety reduction in a clinical population. Biofeedback Self Regul. 1990 Sep;15(3):273-84. doi: 10.1007/BF01011109.
citation: Eisen AR, Rapee RM, Barlow DH. The effects of breathing rate and pCO2 levels on relaxation and anxiety in a non-clinical population. Journal of Anxiety Disorders 1990;4(3):183-90
citation: Hazlett-Stevens H, Craske MG. BREATHING RETRAINING AND DIAPHRAGMATIC BREATHING. In General principles and empirically supported techniques of cognitive behavior therapy. 2009.
citation: Zhao I, Yates P. Non-pharmacological interventions for breathlessness management in patients with lung cancer: a systematic review. Palliat Med. 2008 Sep;22(6):693-701. doi: 10.1177/0269216308095024.
citation: Bredin M, Corner J, Krishnasamy M, Plant H, Bailey C, A'Hern R. Multicentre randomised controlled trial of nursing intervention for breathlessness in patients with lung cancer. BMJ. 1999 Apr 3;318(7188):901-4. doi: 10.1136/bmj.318.7188.901.
citation: Corner J, Plant H, A'Hern R, Bailey C. Non-pharmacological intervention for breathlessness in lung cancer. Palliat Med. 1996 Oct;10(4):299-305. doi: 10.1177/026921639601000405.
citation: Schein MH, Gavish B, Herz M, Rosner-Kahana D, Naveh P, Knishkowy B, Zlotnikov E, Ben-Zvi N, Melmed RN. Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study. J Hum Hypertens. 2001 Apr;15(4):271-8. doi: 10.1038/sj.jhh.1001148.
citation: Elliot WJ, Izzo JL Jr, White WB, Rosing DR, Snyder CS, Alter A, Gavish B, Black HR. Graded blood pressure reduction in hypertensive outpatients associated with use of a device to assist with slow breathing. J Clin Hypertens (Greenwich). 2004 Oct;6(10):553-9; quiz 560-1. doi: 10.1111/j.1524-6175.2004.03553.x.
citation: Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Bilo HJ. Effect of device-guided breathing exercises on blood pressure in hypertensive patients with type 2 diabetes mellitus: a randomized controlled trial. J Hypertens. 2007 Jan;25(1):241-6. doi: 10.1097/HJH.0b013e32801040d5.
citation: Meles E, Giannattasio C, Failla M, Gentile G, Capra A, Mancia G. Nonpharmacologic treatment of hypertension by respiratory exercise in the home setting. Am J Hypertens. 2004 Apr;17(4):370-4. doi: 10.1016/j.amjhyper.2003.12.009.
citation: Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011.
citation: Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. doi: 10.1038/sj.jhh.1001147.
citation: Schein MH, Gavish B, Baevsky T, Kaufman M, Levine S, Nessing A, Alter A. Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial. J Hum Hypertens. 2009 May;23(5):325-31. doi: 10.1038/jhh.2008.135. Epub 2008 Nov 13.
citation: Ekman I, Kjellstrom B, Falk K, Norman J, Swedberg K. Impact of device-guided slow breathing on symptoms of chronic heart failure: a randomized, controlled feasibility study. Eur J Heart Fail. 2011 Sep;13(9):1000-5. doi: 10.1093/eurjhf/hfr090. Epub 2011 Jul 28.
citation: Parati G, Malfatto G, Boarin S, Branzi G, Caldara G, Giglio A, Bilo G, Ongaro G, Alter A, Gavish B, Mancia G. Device-guided paced breathing in the home setting: effects on exercise capacity, pulmonary and ventricular function in patients with chronic heart failure: a pilot study. Circ Heart Fail. 2008 Sep;1(3):178-83. doi: 10.1161/CIRCHEARTFAILURE.108.772640.
citation: Reiner R. Integrating a portable biofeedback device into clinical practice for patients with anxiety disorders: results of a pilot study. Appl Psychophysiol Biofeedback. 2008 Mar;33(1):55-61. doi: 10.1007/s10484-007-9046-6. Epub 2008 Feb 20.
citation: Jacobsen PB, Jim HS. Psychosocial interventions for anxiety and depression in adult cancer patients: achievements and challenges. CA Cancer J Clin. 2008 Jul-Aug;58(4):214-30. doi: 10.3322/CA.2008.0003. Epub 2008 Jun 16.
citation: Mehta KM, Yaffe K, Brenes GA, Newman AB, Shorr RI, Simonsick EM, Ayonayon HN, Rubin SM, Covinsky KE. Anxiety symptoms and decline in physical function over 5 years in the health, aging and body composition study. J Am Geriatr Soc. 2007 Feb;55(2):265-70. doi: 10.1111/j.1532-5415.2007.01041.x.
citation: Schneider S, Moyer A, Knapp-Oliver S, Sohl S, Cannella D, Targhetta V. Pre-intervention distress moderates the efficacy of psychosocial treatment for cancer patients: a meta-analysis. J Behav Med. 2010 Feb;33(1):1-14. doi: 10.1007/s10865-009-9227-2. Epub 2009 Sep 27.
citation: Weaver KE, Forsythe LP, Reeve BB, Alfano CM, Rodriguez JL, Sabatino SA, Hawkins NA, Rowland JH. Mental and physical health-related quality of life among U.S. cancer survivors: population estimates from the 2010 National Health Interview Survey. Cancer Epidemiol Biomarkers Prev. 2012 Nov;21(11):2108-17. doi: 10.1158/1055-9965.EPI-12-0740. Epub 2012 Oct 30.
citation: Burris JL, Andrykowski M. Disparities in mental health between rural and nonrural cancer survivors: a preliminary study. Psychooncology. 2010 Jun;19(6):637-45. doi: 10.1002/pon.1600.
citation: Hewitt M, Greenfield S, Stovall E. From cancer patient to cancer survivor: Lost in Transition. 2006. National Academies Press.
citation: Stamm BH, Piland NF, Lambert D, Speck NC. A Rural Perspective on Health Care for the Whole Person. Professional Psychology: Research and Practice 2007;38(3):298-304
citation: American Psychological Association, Practice Directorate, Office of Rural Health (2002a). Caring for the rural community: 2000-2001 report. Washington, DC: APA Press; 2001.
citation: Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses. 2006;67(3):566-71. doi: 10.1016/j.mehy.2006.02.042. Epub 2006 Apr 18.
citation: Carrieri-Kohlman V, Gormley JM, Douglas MK, Paul SM, Stulbarg MS. Exercise training decreases dyspnea and the distress and anxiety associated with it. Monitoring alone may be as effective as coaching. Chest. 1996 Dec;110(6):1526-35. doi: 10.1378/chest.110.6.1526.
citation: Gallo-Silver L, Pollack B. Behavioral interventions for lung cancer-related breathlessness. Cancer Pract. 2000 Nov-Dec;8(6):268-73. doi: 10.1046/j.1523-5394.2000.86005.x.
citation: Tanaka K, Akechi T, Okuyama T, Nishiwaki Y, Uchitomi Y. Development and validation of the Cancer Dyspnoea Scale: a multidimensional, brief, self-rating scale. Br J Cancer. 2000 Feb;82(4):800-5. doi: 10.1054/bjoc.1999.1002.
citation: Dudgeon DJ, Lertzman M. Dyspnea in the advanced cancer patient. J Pain Symptom Manage. 1998 Oct;16(4):212-9. doi: 10.1016/s0885-3924(98)00065-7.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
citation: Luckett T, Butow PN, King MT, Oguchi M, Heading G, Hackl NA, Rankin N, Price MA. A review and recommendations for optimal outcome measures of anxiety, depression and general distress in studies evaluating psychosocial interventions for English-speaking adults with heterogeneous cancer diagnoses. Support Care Cancer. 2010 Oct;18(10):1241-62. doi: 10.1007/s00520-010-0932-8. Epub 2010 Jul 2.
citation: Dyspnea. Mechanisms, assessment, and management: a consensus statement. American Thoracic Society. Am J Respir Crit Care Med. 1999 Jan;159(1):321-40. doi: 10.1164/ajrccm.159.1.ats898. No abstract available.
citation: Polanski J, Chabowski M, Chudiak A, Uchmanowicz B, Janczak D, Rosinczuk J, Mazur G. Intensity of Anxiety and Depression in Patients with Lung Cancer in Relation to Quality of Life. Adv Exp Med Biol. 2018;1023:29-36. doi: 10.1007/5584_2017_50.
citation: Krebber AM, Jansen F, Witte BI, Cuijpers P, de Bree R, Becker-Commissaris A, Smit EF, van Straten A, Eeckhout AM, Beekman AT, Leemans CR, Verdonck-de Leeuw IM. Stepped care targeting psychological distress in head and neck cancer and lung cancer patients: a randomized, controlled trial. Ann Oncol. 2016 Sep;27(9):1754-60. doi: 10.1093/annonc/mdw230. Epub 2016 Jun 10.
citation: Quist M, Langer SW, Rorth M, Christensen KB, Adamsen L. "EXHALE": exercise as a strategy for rehabilitation in advanced stage lung cancer patients: a randomized clinical trial comparing the effects of 12 weeks supervised exercise intervention versus usual care for advanced stage lung cancer patients. BMC Cancer. 2013 Oct 14;13:477. doi: 10.1186/1471-2407-13-477.
citation: Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.
citation: Gift AG. Validation of a vertical visual analogue scale as a measure of clinical dyspnea. Rehabil Nurs. 1989 Nov-Dec;14(6):323-5. doi: 10.1002/j.2048-7940.1989.tb01129.x.
citation: Mancini I, Body JJ. Assessment of dyspnea in advanced cancer patients. Support Care Cancer. 1999 Jul;7(4):229-32. doi: 10.1007/s005200050254.
citation: Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA. Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects. Spine (Phila Pa 1976). 2001 Jul 1;26(13):1418-24. doi: 10.1097/00007632-200107010-00005.
citation: Linde K, Witt CM, Streng A, Weidenhammer W, Wagenpfeil S, Brinkhaus B, Willich SN, Melchart D. The impact of patient expectations on outcomes in four randomized controlled trials of acupuncture in patients with chronic pain. Pain. 2007 Apr;128(3):264-271. doi: 10.1016/j.pain.2006.12.006. Epub 2007 Jan 25.
citation: Cancer of the Lung and Bronchus - SEER Stat Fact Sheets [Internet]. [cited 2012 Jul 17]. Available from: http://seer.cancer.gov/statfacts/html/lungb.html
citation: Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep. 1985 Dec;69(12):1375-81.
citation: Wilson EB. Probable inference, the law of succession, and statistical inference. JASA1927;22: 209-212.
citation: Garcia SF, George J, Rosenbloom SK, Cella D. Adapting chronic illness health related quality of life item banks for cancer populations. In Poster presented at the International Society for Quality of LifeResearch on Patient-Reported Outcomes in Clinical Practice, Budapest, Hungary. In 2007.
citation: Molassiotis A, Ellis J, Wagland R, Williams ML, Bailey CD, Booton R, Blackhall F, Yorke J, Smith JA. The Manchester cough in lung cancer scale: the development and preliminary validation of a new assessment tool. J Pain Symptom Manage. 2013 Feb;45(2):179-90. doi: 10.1016/j.jpainsymman.2012.01.015. Epub 2012 Aug 25.
citation: Uddin M, Aiello AE, Wildman DE, Koenen KC, Pawelec G, de Los Santos R, Goldmann E, Galea S. Epigenetic and immune function profiles associated with posttraumatic stress disorder. Proc Natl Acad Sci U S A. 2010 May 18;107(20):9470-5. doi: 10.1073/pnas.0910794107. Epub 2010 May 3.
citation: Uddin M, Koenen KC, Aiello AE, Wildman DE, de los Santos R, Galea S. Epigenetic and inflammatory marker profiles associated with depression in a community-based epidemiologic sample. Psychol Med. 2011 May;41(5):997-1007. doi: 10.1017/S0033291710001674. Epub 2010 Sep 14.
citation: El-Sayed AM, Haloossim MR, Galea S, Koenen KC. Epigenetic modifications associated with suicide and common mood and anxiety disorders: a systematic review of the literature. Biol Mood Anxiety Disord. 2012 Jun 14;2:10. doi: 10.1186/2045-5380-2-10.
citation: Weaver IC, Cervoni N, Champagne FA, D'Alessio AC, Sharma S, Seckl JR, Dymov S, Szyf M, Meaney MJ. Epigenetic programming by maternal behavior. Nat Neurosci. 2004 Aug;7(8):847-54. doi: 10.1038/nn1276. Epub 2004 Jun 27.
citation: Aldwin, C M, The physiology of stress, in Stress, Coping, and Development Guilford Press: New York, NY. 2007; 39-54.
citation: Murphy SE, Braithwaite EC, Hubbard I, Williams KV, Tindall E, Holmes EA, Ramchandani PG. Salivary cortisol response to infant distress in pregnant women with depressive symptoms. Arch Womens Ment Health. 2015 Apr;18(2):247-253. doi: 10.1007/s00737-014-0473-0. Epub 2014 Oct 29.
citation: Schrepf A, Clevenger L, Christensen D, DeGeest K, Bender D, Ahmed A, Goodheart MJ, Dahmoush L, Penedo F, Lucci JA 3rd, Ganjei-Azar P, Mendez L, Markon K, Lubaroff DM, Thaker PH, Slavich GM, Sood AK, Lutgendorf SK. Cortisol and inflammatory processes in ovarian cancer patients following primary treatment: relationships with depression, fatigue, and disability. Brain Behav Immun. 2013 Mar;30 Suppl(0):S126-34. doi: 10.1016/j.bbi.2012.07.022. Epub 2012 Aug 5.
citation: Stoppelbein L, Greening L. A longitudinal study of the role of cortisol in posttraumatic stress disorder symptom clusters. Anxiety Stress Coping. 2015;28(1):17-30. doi: 10.1080/10615806.2014.923844. Epub 2014 Jun 17.
citation: Vadiraja HS, Raghavendra RM, Nagarathna R, Nagendra HR, Rekha M, Vanitha N, Gopinath KS, Srinath BS, Vishweshwara MS, Madhavi YS, Ajaikumar BS, Ramesh BS, Nalini R, Kumar V. Effects of a yoga program on cortisol rhythm and mood states in early breast cancer patients undergoing adjuvant radiotherapy: a randomized controlled trial. Integr Cancer Ther. 2009 Mar;8(1):37-46. doi: 10.1177/1534735409331456. Epub 2009 Feb 3.
citation: Cruess DG, Antoni MH, McGregor BA, Kilbourn KM, Boyers AE, Alferi SM, Carver CS, Kumar M. Cognitive-behavioral stress management reduces serum cortisol by enhancing benefit finding among women being treated for early stage breast cancer. Psychosom Med. 2000 May-Jun;62(3):304-8. doi: 10.1097/00006842-200005000-00002.
citation: Nickel C, Tanca S, Kolowos S, Pedrosa-Gil F, Bachler E, Loew TH, Gross M, Rother WK, Nickel MK. Men with chronic occupational stress benefit from behavioural/psycho-educational group training: a randomized, prospective, controlled trial. Psychol Med. 2007 Aug;37(8):1141-9. doi: 10.1017/S0033291706009445. Epub 2006 Dec 6.
citation: Boyes A, D'Este C, Carey M, Lecathelinais C, Girgis A. How does the Distress Thermometer compare to the Hospital Anxiety and Depression Scale for detecting possible cases of psychological morbidity among cancer survivors? Support Care Cancer. 2013 Jan;21(1):119-27. doi: 10.1007/s00520-012-1499-3. Epub 2012 May 24.
citation: Donovan KA, Grassi L, McGinty HL, Jacobsen PB. Validation of the distress thermometer worldwide: state of the science. Psychooncology. 2014 Mar;23(3):241-50. doi: 10.1002/pon.3430. Epub 2013 Nov 11.
citation: Ma X, Zhang J, Zhong W, Shu C, Wang F, Wen J, Zhou M, Sang Y, Jiang Y, Liu L. The diagnostic role of a short screening tool--the distress thermometer: a meta-analysis. Support Care Cancer. 2014 Jul;22(7):1741-55. doi: 10.1007/s00520-014-2143-1. Epub 2014 Feb 8.
citation: Custers JA, van den Berg SW, van Laarhoven HW, Bleiker EM, Gielissen MF, Prins JB. The Cancer Worry Scale: detecting fear of recurrence in breast cancer survivors. Cancer Nurs. 2014 Jan-Feb;37(1):E44-50. doi: 10.1097/NCC.0b013e3182813a17.