Clinical trial NCT03500393: A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation (REM)
Official title: A Remotely Supervised Exercise Program for Lung Cancer Patients Undergoing Chemoradiation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the remotely supervised exercise (REM) or the unsupervised exercise (UNSUP) arm upon completion of the baseline assessment battery.
Primary purpose: OTHER

Brief summary: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely supervised exercise program (REM) in promoting adherence to an exercise prescription before and during chemoradiation.

Detailed description: The research team adopts an overtly pragmatic approach where our design choices are made to enhance external validity and create a parsimonious intervention that can be integrated into busy clinical practices. This is a pilot study and is not designed to definitively provide evidence for a treatment effect, but rather to establish feasibility and to optimize the intervention and study procedures in preparation for a larger trial. We will conduct a pilot RCT comparing a remotely supervised exercise program (REM) to an unsupervised exercise program (UNSUP). Data will be collected upon enrollment (T0; at least 2 weeks prior to beginning chemoradiation), immediately prior to chemoradiation (T1), immediately post-chemoradiation (T2) and 1-month post-chemoradiation (T3).

Eligibility criteria: Inclusion Criteria:

* Are over the age of 18 and diagnosed with Stage IIa to IIIb lung cancer;
* Definitive treatment with chemoradiation with weekly carboplatin and paclitaxel concurrent with radiation is planned to begin in no less than 2 weeks;
* Have an Apple or Android device with capacity to install a fitness device app and access to either WiFi or cellular service;
* Are English-speaking and able to provide voluntary, written consent;
* Able to tolerate chemoradiation as indicated by Zubrod/ECOG Performance Status 0-1; CBC/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl;Adequate renal function within 14 days prior to registration, defined as creatinine clearance must be at least 35 ml/min; Adequate hepatic function within 14 days prior to registration, defined as total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution and ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution; No prior thoracic radiation therapy;

Exclusion Criteria:

* Life expectancy of \< 12 months or are receiving hospice services;
* Psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
* Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of \>120bpm, blood pressure \>180/100mmHg or unstable angina 40 or musculoskeletal issue preventing exercise;
* Are unable to walk 100 meters. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe;
* Less than 2 weeks to the beginning of chemoradiation;
* Physician discretion;
* Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.

Primary outcomes:
measure: Recruitment and retention statistics
timeFrame: Time 3, One month after completing chemoradiation
Secondary outcomes:
measure: Minutes spent in exercise
timeFrame: Time 3, One month after completing chemoradiation
measure: 6-minute walk test
timeFrame: Time 3, One month after completing chemoradiation
measure: Timed up-and-go test
timeFrame: Time 3, One month after completing chemoradiation
measure: Five times sit-to-stand test
timeFrame: Time 3, One month after completing chemoradiation
measure: Forced expiratory volume in 1 second
timeFrame: Time 3, One month after completing chemoradiation
measure: Diffusion capacity
timeFrame: Time 3, One month after completing chemoradiation
measure: Forced vital capacity
timeFrame: Time 3, One month after completing chemoradiation
measure: Physical Function Scale of the Patient Reported Outcomes Measurement information System (PROMIS)
timeFrame: Time 3, One month after completing chemoradiation
measure: Pittsburgh Sleep Quality Index
timeFrame: Time 3, One month after completing chemoradiation
measure: Functional Assessment of Cancer Therapy-fatigue scale
timeFrame: Time 3, One month after completing chemoradiation
measure: Dose reductions
timeFrame: Time 3, One month after completing chemoradiation
measure: Grip strength
timeFrame: Time 3, one month after completing chemoradiation
Other outcomes:
measure: Physical Activity Acceptance Questionnaire
timeFrame: Time 2, Assessment immediately after completing chemoradiation
measure: Lymphocyte subsets
timeFrame: Time 3, One month after completing chemoradiation
measure: Inflammatory cytokines
timeFrame: Time 3, One month after completing chemoradiation
measure: Stress hormones
timeFrame: Time 3, One month after completing chemoradiation
Locations:
city: Hanover
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Kathleen Lyons, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Cancer Society. Cancer Facts and Figures 2016. Atlanta, GA2016
citation: Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.
citation: Margaritora S, Cesario A, Cusumano G, Cafarotti S, Corbo GM, Ferri L, Ceppi M, Meacci E, Valente S, D'Angelillo RM, Russo P, Porziella V, Bonassi S, Pasqua F, Sterzi S, Granone P. Is pulmonary function damaged by neoadjuvant lung cancer therapy? A comprehensive serial time-trend analysis of pulmonary function after induction radiochemotherapy plus surgery. J Thorac Cardiovasc Surg. 2010 Jun;139(6):1457-63. doi: 10.1016/j.jtcvs.2009.10.023. Epub 2010 Apr 2.
citation: Pasqua F, Biscione G, Crigna G, Auciello L, Cazzola M. Combining triple therapy and pulmonary rehabilitation in patients with advanced COPD: a pilot study. Respir Med. 2010 Mar;104(3):412-7. doi: 10.1016/j.rmed.2009.10.005. Epub 2009 Nov 4.
citation: Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
citation: Jackson W, Alexander N, Schipper M, Fig L, Feng F, Jolly S. Characterization of changes in total body composition for patients with head and neck cancer undergoing chemoradiotherapy using dual-energy x-ray absorptiometry. Head Neck. 2014 Sep;36(9):1356-62. doi: 10.1002/hed.23461. Epub 2013 Nov 21.
citation: Carli F, Scheede-Bergdahl C. Prehabilitation to enhance perioperative care. Anesthesiol Clin. 2015 Mar;33(1):17-33. doi: 10.1016/j.anclin.2014.11.002. Epub 2015 Jan 9.
citation: Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
citation: Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care. 2005 Jan;8(1):23-32. doi: 10.1097/00075197-200501000-00005.
citation: Jones LW, Watson D, Herndon JE 2nd, Eves ND, Haithcock BE, Loewen G, Kohman L. Peak oxygen consumption and long-term all-cause mortality in nonsmall cell lung cancer. Cancer. 2010 Oct 15;116(20):4825-32. doi: 10.1002/cncr.25396.
citation: Tarumi S, Yokomise H, Gotoh M, Kasai Y, Matsuura N, Chang SS, Go T. Pulmonary rehabilitation during induction chemoradiotherapy for lung cancer improves pulmonary function. J Thorac Cardiovasc Surg. 2015 Feb;149(2):569-73. doi: 10.1016/j.jtcvs.2014.09.123. Epub 2014 Oct 5.
citation: Yeh SH, Lai HL, Hsiao CY, Lin LW, Chuang YK, Yang YY, Yang KD. Moderate physical activity of music aerobic exercise increases lymphocyte counts, specific subsets, and differentiation. J Phys Act Health. 2014 Sep;11(7):1386-92. doi: 10.1123/jpah.2012-0508. Epub 2013 Dec 20.
citation: Wang R, Liu J, Chen P, Yu D. Regular tai chi exercise decreases the percentage of type 2 cytokine-producing cells in postsurgical non-small cell lung cancer survivors. Cancer Nurs. 2013 Jul-Aug;36(4):E27-34. doi: 10.1097/NCC.0b013e318268f7d5.
citation: Silver JK. Cancer prehabilitation and its role in improving health outcomes and reducing health care costs. Semin Oncol Nurs. 2015 Feb;31(1):13-30. doi: 10.1016/j.soncn.2014.11.003. Epub 2014 Dec 3.
citation: Kleinman MS, Mold JW. Defining the components of the research pipeline. Clin Transl Sci. 2009 Aug;2(4):312-4. doi: 10.1111/j.1752-8062.2009.00119.x.
citation: Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
citation: Jones LW, Viglianti BL, Tashjian JA, Kothadia SM, Keir ST, Freedland SJ, Potter MQ, Moon EJ, Schroeder T, Herndon JE 2nd, Dewhirst MW. Effect of aerobic exercise on tumor physiology in an animal model of human breast cancer. J Appl Physiol (1985). 2010 Feb;108(2):343-8. doi: 10.1152/japplphysiol.00424.2009. Epub 2009 Dec 3.
citation: Moore SC, Lee IM, Weiderpass E, Campbell PT, Sampson JN, Kitahara CM, Keadle SK, Arem H, Berrington de Gonzalez A, Hartge P, Adami HO, Blair CK, Borch KB, Boyd E, Check DP, Fournier A, Freedman ND, Gunter M, Johannson M, Khaw KT, Linet MS, Orsini N, Park Y, Riboli E, Robien K, Schairer C, Sesso H, Spriggs M, Van Dusen R, Wolk A, Matthews CE, Patel AV. Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med. 2016 Jun 1;176(6):816-25. doi: 10.1001/jamainternmed.2016.1548.
citation: Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
citation: Armstrong KW, Bravo-Iniguez CE, Jacobson FL, Jaklitsch MT. Recent trends in surgical research of cancer treatment in the elderly, with a primary focus on lung cancer: Presentation at the 2015 annual meeting of SIOG. J Geriatr Oncol. 2016 Sep;7(5):368-74. doi: 10.1016/j.jgo.2016.07.004. Epub 2016 Jul 25.
citation: Singh F, Newton RU, Galvao DA, Spry N, Baker MK. A systematic review of pre-surgical exercise intervention studies with cancer patients. Surg Oncol. 2013 Jun;22(2):92-104. doi: 10.1016/j.suronc.2013.01.004. Epub 2013 Feb 19.
citation: Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25.
citation: Crandall K, Maguire R, Campbell A, Kearney N. Exercise intervention for patients surgically treated for Non-Small Cell Lung Cancer (NSCLC): a systematic review. Surg Oncol. 2014 Mar;23(1):17-30. doi: 10.1016/j.suronc.2014.01.001. Epub 2014 Jan 24.
citation: Pouwels S, Fiddelaers J, Teijink JA, Woorst JF, Siebenga J, Smeenk FW. Preoperative exercise therapy in lung surgery patients: A systematic review. Respir Med. 2015 Dec;109(12):1495-504. doi: 10.1016/j.rmed.2015.08.009. Epub 2015 Aug 15.
citation: Jones LW, Peddle CJ, Eves ND, Haykowsky MJ, Courneya KS, Mackey JR, Joy AA, Kumar V, Winton TW, Reiman T. Effects of presurgical exercise training on cardiorespiratory fitness among patients undergoing thoracic surgery for malignant lung lesions. Cancer. 2007 Aug 1;110(3):590-8. doi: 10.1002/cncr.22830.
citation: Jones LW, Eves ND, Peterson BL, Garst J, Crawford J, West MJ, Mabe S, Harpole D, Kraus WE, Douglas PS. Safety and feasibility of aerobic training on cardiopulmonary function and quality of life in postsurgical nonsmall cell lung cancer patients: a pilot study. Cancer. 2008 Dec 15;113(12):3430-9. doi: 10.1002/cncr.23967.
citation: Stout NL, Baima J, Swisher AK, Winters-Stone KM, Welsh J. A Systematic Review of Exercise Systematic Reviews in the Cancer Literature (2005-2017). PM R. 2017 Sep;9(9S2):S347-S384. doi: 10.1016/j.pmrj.2017.07.074.
citation: Stene GB, Helbostad JL, Balstad TR, Riphagen II, Kaasa S, Oldervoll LM. Effect of physical exercise on muscle mass and strength in cancer patients during treatment--a systematic review. Crit Rev Oncol Hematol. 2013 Dec;88(3):573-93. doi: 10.1016/j.critrevonc.2013.07.001. Epub 2013 Aug 9.
citation: Hoffman AJ, Brintnall RA, von Eye A, Jones LW, Alderink G, Patzelt LH, Brown JK. Home-based exercise: promising rehabilitation for symptom relief, improved functional status and quality of life for post-surgical lung cancer patients. J Thorac Dis. 2014 Jun;6(6):632-40. doi: 10.3978/j.issn.2072-1439.2014.06.08.
citation: Weinhold M, Shimabukuro-Vornhagen A, Franke A, Theurich S, Wahl P, Hallek M, Schmidt A, Schinkothe T, Mester J, von Bergwelt-Baildon M, Bloch W. Physical exercise modulates the homeostasis of human regulatory T cells. J Allergy Clin Immunol. 2016 May;137(5):1607-1610.e8. doi: 10.1016/j.jaci.2015.10.035. Epub 2016 Jan 7. No abstract available.
citation: Niemela M, Kangastupa P, Niemela O, Bloigu R, Juvonen T. Acute Changes in Inflammatory Biomarker Levels in Recreational Runners Participating in a Marathon or Half-Marathon. Sports Med Open. 2016 Dec;2(1):21. doi: 10.1186/s40798-016-0045-0. Epub 2016 Mar 2.
citation: Treanor C, Kyaw T, Donnelly M. An international review and meta-analysis of prehabilitation compared to usual care for cancer patients. J Cancer Surviv. 2018 Feb;12(1):64-73. doi: 10.1007/s11764-017-0645-9. Epub 2017 Sep 12.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Mesquita R, Wilke S, Smid DE, Janssen DJ, Franssen FM, Probst VS, Wouters EF, Muris JW, Pitta F, Spruit MA. Measurement properties of the Timed Up & Go test in patients with COPD. Chron Respir Dis. 2016 Nov;13(4):344-352. doi: 10.1177/1479972316647178. Epub 2016 Jul 8.
citation: Jones SE, Kon SS, Canavan JL, Patel MS, Clark AL, Nolan CM, Polkey MI, Man WD. The five-repetition sit-to-stand test as a functional outcome measure in COPD. Thorax. 2013 Nov;68(11):1015-20. doi: 10.1136/thoraxjnl-2013-203576. Epub 2013 Jun 19.
citation: Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
citation: Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
citation: Sox HC, Lewis RJ. Pragmatic Trials: Practical Answers to "Real World" Questions. JAMA. 2016 Sep 20;316(11):1205-1206. doi: 10.1001/jama.2016.11409. No abstract available.
citation: Vokes EE, Herndon JE 2nd, Kelley MJ, Cicchetti MG, Ramnath N, Neill H, Atkins JN, Watson DM, Akerley W, Green MR; Cancer and Leukemia Group B. Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable stage III Non-small-cell lung cancer: Cancer and Leukemia Group B. J Clin Oncol. 2007 May 1;25(13):1698-704. doi: 10.1200/JCO.2006.07.3569. Epub 2007 Apr 2.
citation: Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
citation: McDermott MM, Guralnik JM, Criqui MH, Ferrucci L, Liu K, Spring B, Tian L, Domanchuk K, Kibbe M, Zhao L, Lloyd Jones D, Liao Y, Gao Y, Rejeski WJ. Unsupervised exercise and mobility loss in peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2015 May 20;4(5):e001659. doi: 10.1161/JAHA.114.001659.
citation: Michie S, Abraham C, Whittington C, McAteer J, Gupta S. Effective techniques in healthy eating and physical activity interventions: a meta-regression. Health Psychol. 2009 Nov;28(6):690-701. doi: 10.1037/a0016136.
citation: Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982 Jul;92(1):111-35. No abstract available.
citation: Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
citation: Coughlin SS, Stewart J. Use of Consumer Wearable Devices to Promote Physical Activity: A Review of Health Intervention Studies. J Environ Health Sci. 2016 Nov;2(6):10.15436/2378-6841.16.1123. doi: 10.15436/2378-6841.16.1123. Epub 2016 Nov 30.
citation: de Vries HJ, Kooiman TJ, van Ittersum MW, van Brussel M, de Groot M. Do activity monitors increase physical activity in adults with overweight or obesity? A systematic review and meta-analysis. Obesity (Silver Spring). 2016 Oct;24(10):2078-91. doi: 10.1002/oby.21619.
citation: Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.
citation: Mendoza L, Horta P, Espinoza J, Aguilera M, Balmaceda N, Castro A, Ruiz M, Diaz O, Hopkinson NS. Pedometers to enhance physical activity in COPD: a randomised controlled trial. Eur Respir J. 2015 Feb;45(2):347-54. doi: 10.1183/09031936.00084514. Epub 2014 Sep 26.
citation: Kwan BM, Bryan A. In-task and post-task affective response to exercise: translating exercise intentions into behaviour. Br J Health Psychol. 2010 Feb;15(Pt 1):115-31. doi: 10.1348/135910709X433267. Epub 2009 Apr 25.
citation: Schneider M, Dunn A, Cooper D. Affect, exercise, and physical activity among healthy adolescents. J Sport Exerc Psychol. 2009 Dec;31(6):706-23. doi: 10.1123/jsep.31.6.706.
citation: Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
citation: Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
citation: Goodwin CL, Forman EM, Herbert JD, Butryn ML, Ledley GS. A pilot study examining the initial effectiveness of a brief acceptance-based behavior therapy for modifying diet and physical activity among cardiac patients. Behav Modif. 2012 Mar;36(2):199-217. doi: 10.1177/0145445511427770. Epub 2011 Nov 30.
citation: Hawkes AL, Chambers SK, Pakenham KI, Patrao TA, Baade PD, Lynch BM, Aitken JF, Meng X, Courneya KS. Effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes in survivors of colorectal cancer: a randomized controlled trial. J Clin Oncol. 2013 Jun 20;31(18):2313-21. doi: 10.1200/JCO.2012.45.5873. Epub 2013 May 20.
citation: Stevens CJ. Get ACTive! A randomized controlled trial of feasibility and effectiveness of an acceptance-based behavioral intervention to promote exercise adoption and maintenance. 2016.
citation: Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005 Jan;186:11-7. doi: 10.1192/bjp.186.1.11.
citation: Gabrielson DK, Scaffidi D, Leung E, Stoyanoff L, Robinson J, Nisenbaum R, Brezden-Masley C, Darling PB. Use of an abridged scored Patient-Generated Subjective Global Assessment (abPG-SGA) as a nutritional screening tool for cancer patients in an outpatient setting. Nutr Cancer. 2013;65(2):234-9. doi: 10.1080/01635581.2013.755554.
citation: Vigano AL, di Tomasso J, Kilgour RD, Trutschnigg B, Lucar E, Morais JA, Borod M. The abridged patient-generated subjective global assessment is a useful tool for early detection and characterization of cancer cachexia. J Acad Nutr Diet. 2014 Jul;114(7):1088-1098. doi: 10.1016/j.jand.2013.09.027. Epub 2014 Jan 24.
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
citation: Alley DE, Shardell MD, Peters KW, McLean RR, Dam TT, Kenny AM, Fragala MS, Harris TB, Kiel DP, Guralnik JM, Ferrucci L, Kritchevsky SB, Studenski SA, Vassileva MT, Cawthon PM. Grip strength cutpoints for the identification of clinically relevant weakness. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):559-66. doi: 10.1093/gerona/glu011.
citation: Butryn ML, Arigo D, Raggio GA, Kaufman AI, Kerrigan SG, Forman EM. Measuring the Ability to Tolerate Activity-Related Discomfort: Initial Validation of the Physical Activity Acceptance Questionnaire (PAAQ). J Phys Act Health. 2015 May;12(5):717-6. doi: 10.1123/jpah.2013-0338. Epub 2014 Aug 7.
citation: Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.
citation: Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-291.
citation: Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9.
citation: Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
citation: Hegel MT, Lyons KD, Hull JG, Kaufman P, Urquhart L, Li Z, Ahles TA. Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy. Psychooncology. 2011 Oct;20(10):1092-101. doi: 10.1002/pon.1830. Epub 2010 Sep 5.
citation: Lyons KD, Newman RM, Kaufman PA, Bruce ML, Stearns DM, Lansigan F, Chamberlin M, Bartels SJ, Whipple J, Hegel MT. Goal Attainment and Goal Adjustment of Older Adults During Person-Directed Cancer Rehabilitation. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205110p1-7202205110p8. doi: 10.5014/ajot.2018.023648.
citation: Lyons KD, Hull JG, Kaufman PA, Li Z, Seville JL, Ahles TA, Kornblith AB, Hegel MT. Development and initial evaluation of a telephone-delivered, behavioral activation, and problem-solving treatment program to address functional goals of breast cancer survivors. J Psychosoc Oncol. 2015;33(2):199-218. doi: 10.1080/07347332.2014.1002659. Epub 2015 Feb 10.