Perioperative rehabilitation in operation for lung cancer (PROLUCA) – rationale and design

BMC Cancer

Henning Langberg⁵  Jesper H Pedersen⁴  Paul Clementsen¹  Carsten Hendriksen⁷  Seppo W Langer³  Klaus R Larsen⁶  Merete Christensen⁴  Malene Missel⁴  Jette Vibe-Petersen²  Karen Trier²  Maja S Sommer² 

[1]Department of Pulmonary Medicine, Copenhagen University Hospital Gentofte, Niels Andersens Vej 65, DK-2900 Hellerup, Denmark

[2]Copenhagen Centre for Cancer and Health, Municipality of Copenhagen, Nørre Allé 45, DK-2200 Copenhagen, Denmark

[3]Department of Oncology, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, DK - 2100 Copenhagen, Denmark

[4]Department of Cardiothoracic Surgery RT, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, DK- 2100, Copenhagen, Denmark

[5]CopenRehab, Section of Social Medicine, Department of Public Health and Centre for Healthy Ageing, Faculty of Heath Sciences, University of Copenhagen, Copenhagen, Denmark

[6]Pulmonary Department L, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark

[7]Department of Public Health, Section of Social Medicine, Copenhagen University, Øster Farimagsgade 5, postbox 2099, DK-1014 Copenhagen, Denmark

关键词: NSCLC;    Lung cancer;    Exercise;    Rehabilitation;    Cancer;   

Others  :  858713
DOI  :  10.1186/1471-2407-14-404

 received in 2013-07-10, accepted in 2014-05-13,  发布年份 2014

【 摘 要 】

Background

The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise.

Methods

Using a 2x2 factorial design with continuous effect endpoint (Maximal Oxygen Uptake (VO₂peak)), 380 patients with non-small cell lung cancer (NSCLC) stage I-IIIa referred for surgical resection will be randomly assigned to one of four groups: (1) preoperative and early postoperative rehabilitation (starting two weeks after surgery); (2) preoperative and late postoperative rehabilitation (starting six weeks after surgery); (3) early postoperative rehabilitation alone; (4) today’s standard care which is postoperative rehabilitation initiated six weeks after surgery. The preoperative rehabilitation program consists of an individually designed, 30-minute home-based exercise program performed daily. The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling. The primary study endpoint is VO₂peak and secondary endpoints include: Six-minute walk distance (6MWD), one-repetition-maximum (1RM), pulmonary function, patient-reported outcomes (PROs) on health-related quality of life (HRQoL), symptoms and side effects of the cancer disease and the treatment of the disease, anxiety, depression, wellbeing, lifestyle, hospitalization time, sick leave, work status, postoperative complications (up to 30 days after surgery) and survival. Endpoints will be assessed at baseline, the day before surgery, pre-intervention, post-intervention, six months after surgery and one year after surgery.

Discussion

The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery.

Trial Registration

NCT01893580

【 授权许可】

   
2014 Sommer et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Storm HH, Engholm G, Hakulinen T, Tryggvadóttir L, Klint A, Gislum M, Kejs AMT, Bray F: Survival of patients diagnosed with cancer in the Nordic countries up to 1999–2003 followed to the end of 2006. A critical overview of the results. Acta Oncol 2010, 49:532-544.
• [2]Group DLC: Danish Lunge Cancer Group Annual Report 2011. 2011.
• [3]Fan G, Filipczak L, Chow E: Symptom clusters in cancer patients: a review of the literature. Curr Oncol 2007, 14:173-179.
• [4]Kenny PM, King MT, Viney RC, Boyer MJ, Pollicino CA, McLean JM, Fulham MJ, McCaughan BC: Quality of life and survival in the 2 years after surgery for non small-cell lung cancer. J Clin Oncol 2008, 26:233-241.
• [5]Lim E, Baldwin D, Beckles M, Duffy J, Entwisle J, Faivre-Finn C, Kerr K, Macfie A, McGuigan J, Padley S, Popat S, Screaton N, Snee M, Waller D, Warburton C, Win T: Guidelines on the radical management of patients with lung cancer. Thorax 2010, Suppl 3:1-27.
• [6]Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR: Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol 2009, 10:598-605.
• [7]Kavanagh T: Prediction of long-term prognosis in 12 169 men referred for cardiac rehabilitation. Circulation 2002, 106:666-671.
• [8]Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE: Exercise capacity and mortality among men referred for exercise testing. N Engl J Med 2002, 346:793-801.
• [9]Parsons A, Daley A, Begh R, Aveyard P: Influence of smoking cessation after diagnosis of early stage lung cancer on prognosis: systematic review of observational studies with meta-analysis. BMJ 2010, 340:b5569-b5569.
• [10]Neuenschwander AU, Pedersen JH, Krasnik M, Tønnesen H: Impaired postoperative outcome in chronic alcohol abusers after curative resection for lung cancer. Eur J Cardiothorac Surg 2002, 22:287-291.
• [11]Suemitsu R, Takeo S, Hamatake M, Morokuma A, Suemori Y, Tanaka H: The results of surgery under general anesthesia in patients with lung cancer. Surg Today 2011, 41:60-66.
• [12]Birim O, Kappetein AP, Bogers AJJC: Charlson comorbidity index as a predictor of long-term outcome after surgery for nonsmall cell lung cancer. Eur J Cardiothorac Surg 2005, 28:759-762.
• [13]Jones LW, Eves ND, Kraus WE, Potti A, Crawford J, Blumenthal JA, Peterson BL, Douglas PS: The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design. BMC Cancer 2010, 10:155. BioMed Central Full Text
• [14]Steinberg T, Roseman M, Kasymjanova G, Dobson S, Lajeunesse L, Dajczman E, Kreisman H, MacDonald N, Agulnik J, Cohen V, Rosberger Z, Chasen M, Small D: Prevalence of emotional distress in newly diagnosed lung cancer patients. Support Care Cancer 2009, 17:1493-1497.
• [15]Carlson LE, Groff SL, Maciejewski O, Bultz BD: Screening for distress in lung and breast cancer outpatients: a randomized controlled trial. J Clin Oncol 2010, 28:4884-4891.
• [16]Graves KD, Arnold SM, Love CL, Kirsh KL, Moore PG, Passik SD: Distress screening in a multidisciplinary lung cancer clinic: prevalence and predictors of clinically significant distress. Lung Cancer 2007, 55:215-224.
• [17]Wildgaard K, Ravn J, Nikolajsen L, Jakobsen E, Jensen TS, Kehlet H: Consequences of persistent pain after lung cancer surgery: a nationwide questionnaire study. Acta Anaesthesiol Scand 2011, 55:60-68.
• [18]Jones K, Marie A: Rehabilitation needs of patients with lung cancer after surgery. Cancer Nursing Practice 2009, 8:23-28.
• [19]Carlsen K, Jensen AB, Jacobsen E, Krasnik M, Johansen C: Psychosocial aspects of lung cancer. Lung Cancer 2005, 47:293-300.
• [20]Maliski SL, Sarna L, Evangelista L, Padilla G: The aftermath of lung cancer. Cancer Nurs 2003, 26:237-244.
• [21]Handy JR, Asaph JW, Skokan L, Reed CE, Koh S, Brooks G, Douville EC, Tsen AC, Ott GY, Silvestri GA: What happens to patients undergoing lung cancer surgery? Outcomes and quality of life before and after surgery. Chest 2002, 122:21-30.
• [22]Sarna L, Cooley ME, Brown JK: Women with lung cancer: quality of life after thoracotomy. Cancer Nurs 2010, 33:85-92.
• [23]Balduyck B, Hendriks J, Sardari Nia P, Lauwers P, Van Schil P: Quality of life after lung cancer surgery: a review. Minerva Chir 2009, 64:655-663.
• [24]Si M, Rw S, Snyder C, Pm G, Topaloglu O: Exercise interventions on health-related quality of life for people with cancer during active treatment (Review) SUMMARY OF FINDINGS FOR THE MAIN COMPARISON. 2012.
• [25]Adamsen L, Quist M, Andersen C, Moller T, Herrstedt J, Kronborg D, Baadsgaard MT, Vistisen K, Midtgaard J, Christiansen B, Stage M, Kronborg MT, Rorth M: Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial. BMJ 2009, 339:b3410-b3410.
• [26]Granger CL, McDonald CF, Berney S, Chao C, Denehy L: Exercise intervention to improve exercise capacity and health related quality of life for patients with Non-small cell lung cancer: a systematic review. Lung Cancer 2011, 72:139-153.
• [27]Benzo R, Kelley GA, Recchi L, Hofman A, Sciurba F: Complications of lung resection and exercise capacity: a meta-analysis. Respir Med 2007, 101:1790-1797.
• [28]Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S: The prevalence of psychological distress by cancer site. Psychooncology 2001, 10:19-28.
• [29]Doyle C, Kushi LH, Byers T, Courneya KS, Demark-Wahnefried W, Grant B, McTiernan A, Rock CL, Thompson C, Gansler T, Andrews KS: Nutrition and physical activity during and after cancer treatment: an American cancer society guide for informed choices. CA Cancer J Clin 2006, 56:323-353.
• [30]Irwin ML: Physical activity interventions for cancer survivors. Br J Sports Med 2009, 43:32-38.
• [31]Holmes M, Chen W: Physical activity and survival after breast cancer diagnosis. JAMA 2005, 293:2479-2486.
• [32]Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A, Schilsky RL, Fuchs CS: Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol 2006, 24:3535-3541.
• [33]Friedenreich CM, Gregory J, Kopciuk KA, Mackey JR, Courneya KS, Kopciuk KA, Mackey JR, Courneya KS: Prospective cohort study of lifetime physical activity and breast cancer survival. Int J Cancer 2009, 124:1954-1962.
• [34]Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM: Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst 2012, 104:815-840.
• [35]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, 110:590-598.
• [36]Bobbio A, Chetta A, Ampollini L, Primomo GL, Internullo E, Carbognani P, Rusca M, Olivieri D: Preoperative pulmonary rehabilitation in patients undergoing lung resection for non-small cell lung cancer. Eur J Cardiothorac Surg 2008, 33:95-98.
• [37]Shannon VR: Role of pulmonary rehabilitation in the management of patients with lung cancer. Curr Opin Pulm Med 2010, 16:334-339.
• [38]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, 113:3430-3439.
• [39]Jones LW, Eves ND, Spasojevic I, Wang F, Il’yasova D: Effects of aerobic training on oxidative status in postsurgical non-small cell lung cancer patients: a pilot study. Lung Cancer 2011, 72:45-51.
• [40]Riesenberg H, Lübbe AS: In-patient rehabilitation of lung cancer patients–a prospective study. Support Care Cancer 2010, 18:877-882.
• [41]Spruit MA, Janssen PP, Willemsen SCP, Hochstenbag MMH, Wouters EFM: Exercise capacity before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer patients: a pilot study. Lung Cancer 2006, 52:257-260.
• [42]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, 57:175-180.
• [43]Arbane G, Tropman D, Jackson D, Garrod R: Evaluation of an early exercise intervention after thoracotomy for non-small cell lung cancer (NSCLC), effects on quality of life, muscle strength and exercise tolerance: randomised controlled trial. Lung Cancer 2011, 71:229-234.
• [44]Jones LW, Eves ND, Waner E, Joy AA: Exercise Therapy Across the Lung Cancer Continuum Corresponding author. 2009.
• [45]Rami-Porta R, Crowley JJ, Goldstraw P: The revised TNM staging system for lung cancer. Ann Thorac Cardiovasc Surg 2009, 15:4-9.
• [46]Sørensen JB, Klee M, Palshof T, Hansen HH: Performance status assessment in cancer patients. An inter-observer variability study. Br J Cancer 1993, 67:773-775.
• [47]Metkus TS, Baughman KL, Thompson PD: Exercise prescription and primary prevention of cardiovascular disease. Circulation 2010, 121:2601-4.
• [48]Kreider ME, Grippi MA: Impact of the new ATS/ERS pulmonary function test interpretation guidelines. Respir Med 2007, 101:2336-2342.
• [49]Boutron I, Moher D, Altman D, Schulz K, Ravaud P, Stephenson J, Consort G: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.
• [50]Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee I-M, Nieman DC, Swain DP: American college of sports medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc 2011, 43:1334-1359.
• [51]Ozdem Y, Inanici F, Hasçelik Z: Reduced vital capacity leads to exercise intolerance in patients with ankylosing spondylitis. Eur J Phys Rehabil Med 2011, 47:391-397.
• [52]Quist M, Rørth M, Langer S, Jones LW, Laursen JH, Pappot H, Christensen KB, Adamsen L: Safety and feasibility of a combined exercise intervention for inoperable lung cancer patients undergoing chemotherapy: a pilot study. Lung Cancer 2012, 75:203-208.
• [53]Aaronson N: The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993, 85:365-376.
• [54]Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M: The EORTC QLQ-LC13: a modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC study group on quality of life. Eur J Cancer 1994, 30A:635-642.
• [55]Cella DF, Bonomi AE, Lloyd SR, Tulsky DS, Kaplan E, Bonomi P: Reliability and validity of the functional assessment of cancer therapy-lung (FACT-L) quality of life instrument. Lung Cancer 1995, 12:199-220.
• [56]Ware JE, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483.
• [57]Fredheim OMS, Borchgrevink PC, Saltnes T, Kaasa S: Validation and comparison of the health-related quality-of-life instruments EORTC QLQ-C30 and SF-36 in assessment of patients with chronic nonmalignant pain. J Pain Symptom Manage 2007, 34:657-665.
• [58]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370.
• [59]Bidstrup PE, Mertz BG, Dalton SO, Deltour I, Kroman N, Kehlet H, Rottmann N, Gärtner R, Mitchell AJ, Johansen C: Accuracy of the Danish version of the “distress thermometer”. Psychooncology 2012, 21:436-443.
• [60]Pedersen SS, Spinder H, Erdman RA, Denollet J: Poor perceived social support in implantable cardioverter defibrillator (ICD) patients and their partners: cross-validation of the multidimensional scale of perceived social support. Psychosomatics 2009, 50:461-467.
• [61]Jarden M, Adamsen L, Kjeldsen L, Birgens H, Tolver A, Christensen JF, Stensen M, Sørensen V-A, Møller T: The emerging role of exercise and health counseling in patients with acute leukemia undergoing chemotherapy during outpatient management. Leuk Res 2013, 37:155-161.
• [62]Brooks D, Solway S, Gibbons WJ: ATS statement on six-minute walk test. Am J Respir Crit Care Med 2003, 167:1287.
• [63]Chuang ML, Lin IF, Wasserman K: The body weight-walking distance product as related to lung function, anaerobic threshold and peak VO2 in COPD patients. Respir Med 2001, 95:618-626.
• [64]Brzycki M: Strength testing: predicting a one-rep max from a reps-to-fatigue. J Phys Educ Recr Dance 1993, 64:88-90.
• [65]Holm S: A simpel sequentially recejtive multiple test procedure. Scand J Statist 1997, 6:65-70.
• [66]Missel M, Birkelund R: Living with incurable oesophageal cancer. A phenomenological hermeneutical interpretation of patient stories. Eur J Oncol Nurs 2011, 15:296-301.
• [67]Illingworth N, Forbat L, Hubbard G, Kearney N: The importance of relationships in the experience of cancer: a re-working of the policy ideal of the whole-systems approach. Eur J Oncol Nurs 2010, 14:23-28.
• [68]Lee V: The existential plight of cancer: meaning making as a concrete approach to the intangible search for meaning. Supportive Care Cancer 2008, 16:779-785.
• [69]Sand L, Strang P: Existential loneliness in a palliative home care setting. J Palliat Med 2006, 9:1376-1387.
• [70]Sellman D: Towards an understanding of nursing as a response to human vulnerability. Nurs Philos 2005, 6:2-10.
• [71]Irurita VF, Williams AM: Balancing and compromising: nurses and patients preserving integrity of self and each other. Int J Nurs Stud 2001, 38:579-589.
• [72]Kåresen R, Langmark F: [Psychological, social and economic situation of women surgically treated for cancer]. Tidsskr Nor Laegeforen 2000, 120:2741-2748.
• [73]Stull VB, Snyder DC, Demark-Wahnefried W: Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr 2007, 137:243S-248S.
• [74]Pinto BM, Maruyama NC, Clark MM, Cruess DG, Park E, Roberts M: Motivation to modify lifestyle risk behaviors in women treated for breast cancer. Mayo Clin Proc 2002, 77:122-129.
• [75]Larsen KR, Svendsen UG, Milman N, Brenøe J, Petersen BN: Cardiopulmonary function at rest and during exercise after resection for bronchial carcinoma. Ann Thorac Surg 1997, 64:960-964.