Study protocol: rehabilitation including social and physical activity and education in children and teenagers with cancer (RESPECT)

BMC Cancer

Troels Thorsteinsson⁹  Anne Sofie Helms⁵  Lis Adamsen⁴  Lars Bo Andersen¹¹  Karen Vitting Andersen⁹  Karl Bang Christensen³  Henrik Hasle¹⁰  Carsten Heilmann⁹  Nete Hejgaard¹²  Christoffer Johansen⁸  Marianne Madsen⁹  Svend Aage Madsen⁹  Venka Simovska¹  Birgit Strange⁷  Lone Friis Thing⁶  Peder Skov Wehner²  Kjeld Schmiegelow⁵  Hanne Baekgaard Larsen⁹ 

[1] Department of Education, Aarhus University, Campus Emdrup, Tuborgvej 164, 2400 Copenhagen, Denmark

[2] Department of Pediatric Hematology and Oncology, The H. C. Andersen Children’s Hospital, Odense University Hospital, Sdr. Boulevard 29, 5000 Odense C, Denmark

[3] Department of Biostatistics, The University of Copenhagen, Øster Farimagsgade 5, P.O. Box 2099, , 1014 Copenhagen, Denmark

[4] Department of Public Health and Faculty of Health Sciences, The University Hospitals Centre for Nursing and Care Research (UCSF), Copenhagen University Hospital Rigshospitalet, Ryesgade 27, 2200 Copenhagen, Denmark

[5] Faculty of Health Sciences, The University of Copenhagen, Blegdamsvej 2b, 2100 Copenhagen, Denmark

[6] Department of Nutrition, Exercise and Sports, The University of Copenhagen, Nørre Allé 51-55, 2200 Copenhagen N, Denmark

[7] Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

[8] Department of Oncology, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark

[9] Department of Pediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark

[10] Department of Pediatrics, Aarhus University Hospital, Skejby, Brendstrupgårdsvej 100, 8200 arhus N, Denmark

[11] Institute for Sport Sciences and Clinical Biomechanics, The University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark

[12] Øster Farimagsgade Skole, Øster Farimagsgade 41, 2100 Copenhagen Ø, Denmark

关键词: School reentry;    Controlled;    Peers;    Intervention;    Quality of life;    Physical activity;    Rehabilitation;    Children;    Pediatric;    Cancer;   

Others  :  859254
DOI  :  10.1186/1471-2407-13-544

 received in 2013-07-14, accepted in 2013-10-24,  发布年份 2013

【 摘 要 】

Background

During cancer treatment children have reduced contact with their social network of friends, and have limited participation in education, sports, and leisure activities. During and following cancer treatment, children describe school related problems, reduced physical fitness, and problems related to interaction with peers.

Methods/design

The RESPECT study is a nationwide population-based prospective, controlled, mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark (n = 120) and a matched control group in western Denmark (n = 120). RESPECT includes Danish-speaking children diagnosed with cancer and treated at pediatric oncology units in Denmark. Primary endpoints are the level of educational achievement one year after the cessation of first-line cancer therapy, and the value of VO_2max one year after the cessation of first-line cancer therapy. Secondary endpoints are quality of life measured by validated questionnaires and interviews, and physical performance. RESPECT includes a multimodal intervention program, including ambassador-facilitated educational, physical, and social interventions. The educational intervention includes an educational program aimed at the child with cancer, the child’s schoolteachers and classmates, and the child’s parents. Children with cancer will each have two ambassadors assigned from their class. The ambassadors visit the child with cancer at the hospital at alternating 2-week intervals and participate in the intervention program. The physical and social intervention examines the effect of early, structured, individualized, and continuous physical activity from diagnosis throughout the treatment period. The patients are tested at diagnosis, at 3 and 6 months after diagnosis, and one year after the cessation of treatment. The study is powered to quantify the impact of the combined educational, physical, and social intervention programs.

Discussion

RESPECT is the first population-based study to examine the effect of early rehabilitation for children with cancer, and to use healthy classmates as ambassadors to facilitate the normalization of social life in the hospital. For children with cancer, RESPECT contributes to expanding knowledge on rehabilitation that can also facilitate rehabilitation of other children undergoing hospitalization for long-term illness.

Trial registration

Clinical Trials.gov: file. NCT01772849 and NCT01772862

【 授权许可】

   
2013 Thorsteinsson et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Brown PD, Olsen JH, Hertz H, Carstensen B, Bautz A: Survival after childhood cancer in Denmark 1943-1987: a population-based study. Ugeskr Laeger 1996, 158:773-778.
• [2]Gatta G, Zigon G, Capocaccia R, Coebergh JW, Desandes E, Kaatsch P, Pastore G, Peris-Bonet R, Stiller CA, The EUROCARE Working Group l: Survival of European children and young adults with cancer diagnosed 1995-2002. Eur J Cancer 2009, 45:992-1005.
• [3]Smith MA, Seibel NL, Altekruse SF, Ries LA, Melbert DL, O’Leary M, Smith FO, Reaman GHL: Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol 2010, 28:2625-2634.
• [4]Lund LW, Schmiegelow K, Rechnitzer C, Johansen C: A systematic review of studies on psychosocial late effects of childhood cancer: structures of society and methodological pitfalls may challenge the conclusions. Pediatr Blood Cancer 2011, 56:532-543.
• [5]Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL: Chronic health conditions in adult survivors of childhood cancer. N Engl J Med 2006, 355:1572-1582.
• [6]Vannatta K, Gerhardt CA, Wells RJ, Noll RB: Intensity of CNS treatment for pediatric cancer: prediction of social outcomes in survivors. Pediatr Blood Cancer 2007, 49:716-722.
• [7]Charlton A, Larcombe IJ, Meller ST, Morris Jones PH, Mott MG, Potton MW, Tranmer MD, Walker JJP: Absence from school related to cancer and other chronic conditions. Arch Dis Child 1991, 66:1217-1222.
• [8]Barrera M, Shaw AK, Speechley KN, Maunsell E, Pogany L: Educational and social late effects of childhood cancer and related clinical, personal, and familial characteristics. Cancer 2005, 104:1751-1760.
• [9]Suzuki LK, Kato PM: Psychosocial support for patients in pediatric oncology: the influences of parents, schools, peers, and technology. J Pediatr Oncol Nurs 2003, 20:159-174.
• [10]Adamoli L, Deasy-Spinetta P, Corbetta A, Jankovic M, Lia R, Locati A, Fraschini D, Masera G, Spinetta JJ: School functioning for the child with leukemia in continuous first remission: screening high-risk children. Pediatr Hematol Oncol 1997, 14:121-131.
• [11]Gregory K, Parker L, Craft AW: Returning to primary school after treatment for cancer. Pediatr Hematol Oncol 1994, 11:105-109.
• [12]Gurney JG, Krull KR, Kadan-Lottick N, Nicholson HS, Nathan PC, Zebrack B, Tersak JM, Ness KN: Social outcomes in the childhood cancer survivor study cohort. J Clin Oncol 2009, 27:2390-2395.
• [13]Mitby PA, Robison LL, Whitton JA, Zevon MA, Gibbs IC, Tersak JM, Meadows AT, Stovall M, Zeltzer LK, Mertens AC: Utilization of special education services and educational attainment among long-term survivors of childhood cancer. Cancer 2003, 97:1115-1126.
• [14]Gerhardt CA, Dixon M, Miller K, Vannatta K, Valerius KS, Correll J, Noll RB: Educational and occupational outcomes among survivors of childhood cancer during the transition to emerging adulthood. J Dev Behav Pediatr 2007, 28:448-455.
• [15]Gerhardt CA, Vannatta K, Valerius KS, Correll J, Noll RB: Social and romantic outcomes in emerging adulthood among survivors of childhood cancer. J Adolescent Health 2007, 40:462.e9-462.e15.
• [16]Glaser AW, U CL, Abdul Rashid NF, Walker DA: School behaviour and health status after central nervous system tumours in childhood. Brit J Cancer 1997, 76:643-650.
• [17]Koch SV, Kejs AM, Engholm G, Johansen C, Schmiegelow K: Educational attainment among survivors of childhood cancer: a population-based cohort study in Denmark. Brit J Cancer 2004, 91:923-928.
• [18]Harila-Saari AH, Lähteenmäki PM, Pukkala E, Kyyrönen P, Lanning M, Sankila R: Scholastic achievements of childhood leukemia patients: a nationwide, register-based study. J Clin Oncol 2007, 25:3518-3524.
• [19]Lähteenmäki PM, Huostila J, Hinkka S, Salmi TT: Childhood cancer patients at school. Eur J Cancer 2002, 38:1227-1240.
• [20]Ott JS, Webb TE, Anderson CA, Kastelic JE, Krill CE Jr: Childhood cancer and vulnerability for significant academic underachievement. J Learn Disabil 1982, 15:363-365.
• [21]Katz ER, Varm JW, Rubenstein CL, Blew A, Hubert N: Teacher, parent, and child evaluative ratings of a school reintegration intervention for children with newly diagnosed cancer. Child Health Care 1992, 21:69-75.
• [22]Braam KI, Van Dijk EM, Veening MA, Bierings MB, Merks JH, Grootenhuis MA, Chinapaw MJM, Sinnem G, Takken T, HuisMan J, Kaspers GJL, Broeder ED: Design of the quality of life in motion (QLIM) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical exercise and psychosocial training program to improve physical fitness in children with cancer. BMC Cancer 2010, 10:624. BioMed Central Full Text
• [23]Huang TT, Ness KK: Exercise interventions in children with cancer: a review. Int J Pediatr 2011, 2011:Article ID 461512.
• [24]Winter C, Müller C, Hoffmann C, Boos J, Rosenbaum D: Physical activity and childhood cancer. Pediatr Blood Cancer 2010, 54:501-510.
• [25]San Juan AF, Fleck SJ, Chamorro-Vĩna C, Maté-Mũnoz JL, Moral S, Perez M, et al.: Effects of an intrahospital exercise program intervention for children with leukemia. Med Sci Sport Exer 2007, 39:13-21.
• [26]San Juan AF, Fleck SJ, Chamorro-Vĩna C, Maté-Mũnoz JL, Moral S, Garcia-Castro J, Ramirez M, Madero L, Lucia A: Early-phase adaptations to intrahospital training in strength and functional mobility of children with leukemia. J Strength Cond Res 2007, 21:173-177.
• [27]Stam H, Grootenhuis MA, Last BF: The course of life of survivors of childhood cancer. Psycho-oncol 2005, 14:227-238.
• [28]DuHamel KN, Redd WH, Vickberg SM: Behavioral interventions in the diagnosis, treatment and rehabilitation of children with cancer. Acta Oncol 1999, 38:719-734.
• [29]Lancashire ER, Frobisher C, Reulen RC, Winter DL, Glaser A, Hawkins MM: Educational attainment among adult survivors of childhood cancer in Great Britain: a population-based cohort study. J Natl Cancer Inst 2010, 102:254-270.
• [30]Maurice-Stam H, Silberbusch LM, Last BF, Grootenhuis MA: Evaluation of a psycho-educational group intervention for children treated for cancer: a descriptive pilot study. Psycho-oncol 2009, 18:762-766.
• [31]Mazurek Melnyk B: Intervention studies involving parents of hospitalized young children: an analysis of the past and future recommendations. J Pediatr Nurs 2000, 15:4-13.
• [32]Varni JW, Katz ER, Colegrove R Jr, Dolgin M: The impact of social skills training on the adjustment of children with newly diagnosed cancer. J Pediatr Psychol 1993, 18:751-767.
• [33]Goffman E: The presentation of self in everyday life. New York: Doubleday; 1959.
• [34]Goffman E: Stigma: notes on the management of spoiled identity. New York: Touchstone; 1963.
• [35]Misztal BA: Normality and trust in Goffman’s theory of interaction order. Sociol Theor 2001, 19:312-324.
• [36]Collins R: Stratification: a micro–macro theory of inequality. Sociol Theor 2000, 18:17-43.
• [37]Scheff TJ: Shame and the social bond: a sociological theory. Sociol Theor 2000, 18:84-99.
• [38]Simovska V: Learning by interaction: learning about health through participation and action–the health promoting schools perspective. Copenhagen: Danmarks Lærerhøjskole; 2005.
• [39]Godfrey S, Davies CTM, Wozniak E, Barnes CA: Cardio-respiratory response to exercise in normal children. Clin Sci 1971, 40:419-431.
• [40]Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P: The PedsQL™ in pediatric cancer: reliability and validity of the pediatric quality of life inventory™ generic core scales, multidimensional fatigue scale, and cancer module. Cancer 2002, 94:2090-2106.
• [41]Goodman R: The strengths and difficulties questionnaire: a research note. J Child Psychol Psyc 1997, 38:581-586.
• [42]Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE: Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther 2000, 38:835-855.
• [43]Friborg O, Hjemdal O, Rosenvinge JH, Martinussen M: A new rating scale for adult resilience: what are the central protective resources behind healthy adjustment? Int J Meth Psych Res 2003, 12:65-76.
• [44]Asher SR, Wheeler VA: Children’s loneliness: a comparison of rejected and neglected peer status. J Consult Clin Psych 1985, 53:500-505.
• [45]Horowitz M, Wilner N, Alvarez W: Impact of event scale: a measure of subjective stress. Psychosom Med 1979, 41:209-218.
• [46]Bulowski W, Hoza B: Popularity and friendship: issues, measurement, and outcome. In Peer relationships in child development. Edited by Berndt TJ, Ladd GW. New York: Wiley; 1989:15-45.
• [47]Andersen LB, Andersen TE, Andersen E, Anderssen SA: An intermittent running test to estimate maximal oxygen uptake: the Andersen test. J Sport Med Phys Fit 2008, 48:434-437.
• [48]Shephard RJ, Allen C, Benade AJ, Davies CT, Di Prampero PE, Hedman R, Merriman JE, Myhre K, Simmons R: The maximum oxygen intake: an international reference standard of cardiorespiratory fitness. B World Health Organ 1968, 38:757-764.
• [49]Podsiadlo D, Richardson S: The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991, 39:142-148.
• [50]Bohannon RW: Sit-to-stand test for measuring performance of lower extremity muscles. Percept Motor Skills 1995, 80:163-166.
• [51]Abizanda P, Navarro JL, Garcia-Tomás MI, López-Jiménez E, Martínez-Sánchez E, Paterna G: Validity and usefulness of hand-held dynamometry for measuring muscle strength in community-dwelling older persons. Arch Gerontol Geriat 2012, 54:21-27.
• [52]Deforche B, Lefevre J, De Bourdeauhuij I, Hills AP, Duquet W, Bouckaert J: Physical fitness and physical activity in obese and nonobese Flemish youth. Obesity 2003, 11:434-441.
• [53]McCullagh P: Regression models for ordinal data. J Roy Stat Soc B 1980, 42:109-142.
• [54]Muthén B: A general structural equation model with dichotomous, ordered categorical, and continous latent variable indicators. Psychometrika 1984, 49:115-132.
• [55]Rognmo Ø, Hetland E, Helgerud J, Hoff J, Slørdahl SA: High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiov Prev R 2004, 11:216-222.
• [56]Galvão DA, Newton RU: Review of exercise intervention studies in cancer patients. J Clin Oncol 2005, 23:899-909.