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Open Access 01-12-2016 | Study protocol

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial

Authors: Dimitrios A. Koutoukidis, Rebecca J. Beeken, Ranjit Manchanda, Matthew Burnell, M. Tish Knobf, Anne Lanceley

Published in: Trials | Issue 1/2016

Abstract

Background

Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity.

Methods/design

This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention.

Discussion

The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population.

Trial Registration

ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.

Available only for authorised users

ONS. Cancer Statistics Registrations, England (Series MB1), No. 43, 2012 Release: 10 most common cancers among males and females. 2014. http://webarchive.nationalarchives.gov.uk/20160105160709/http://www.ons.gov.uk/ons/rel/vsob1/cancer-statistics-registrations--england--series-mb1-/no--43--2012/info-most-common-cancers.html. Accessed 04 Oct 2014.

WCRF. Continuous Update Project Report. Food, Nutrition, Physical Activity, and the Prevention of Endometrial Cancer: World Cancer Research Fund 2013 Contract No.: 10 Nov 2013.

Koutoukidis DA, Knobf MT, Lanceley A. Obesity, diet, physical activity, and health-related quality of life in endometrial cancer survivors. Nutr Rev. 2015;73(6):399–408. doi:10.1093/nutrit/nuu063.CrossRefPubMedPubMedCentral

Arem H, Irwin ML. Obesity and endometrial cancer survival: a systematic review. Int J Obesity (2005). 2013;37(5):634–9. doi:10.1038/ijo.2012.94.CrossRef

Boyle T, Fritschi L, Platell C, Heyworth J. Lifestyle factors associated with survival after colorectal cancer diagnosis. Br J Cancer. 2013;109(3):814–22. doi:10.1038/bjc.2013.310.CrossRefPubMedPubMedCentral

Richman EL, Kenfield SA, Chavarro JE, Stampfer MJ, Giovannucci EL, Willett WC, et al. Fat intake after diagnosis and risk of lethal prostate cancer and all-cause mortality. JAMA Intern Med. 2013;173(14):1318–26. doi:10.1001/jamainternmed.2013.6536.CrossRefPubMedPubMedCentral

Bradshaw PT, Ibrahim JG, Khankari N, Cleveland RJ, Abrahamson PE, Stevens J, et al. Post-diagnosis physical activity and survival after breast cancer diagnosis: the Long Island Breast Cancer Study. Breast Cancer Res Treat. 2014;145(3):735–42. doi:10.1007/s10549-014-2966-y.CrossRefPubMedPubMedCentral

WCRF. Continuous Update Project Report: Diet, Nutrition, Physical Activity, and Breast Cancer Survivors. London: World Cancer Research Fund International; 2014.

Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, et al. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012;62(4):243–74. doi:10.3322/caac.21142.CrossRefPubMed

10.

von Gruenigen VE, Waggoner SE, Frasure HE, Kavanagh MB, Janata JW, Rose PG, et al. Lifestyle challenges in endometrial cancer survivorship. Obstet Gynecol. 2011;117(1):93–100. doi:10.1097/AOG.0b013e31820205b3.CrossRef

11.

Demark-Wahnefried W, Aziz NM, Rowland JH, Pinto BM. Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. J Clin Oncol. 2005;23(24):5814–30. doi:10.1200/JCO.2005.01.230.CrossRefPubMedPubMedCentral

12.

Williams K, Steptoe A, Wardle J. Is a cancer diagnosis a trigger for health behaviour change? Findings from a prospective, population-based study. Br J Cancer. 2013;108(11):2407–12. doi:10.1038/bjc.2013.254.CrossRefPubMedPubMedCentral

13.

Pinto BM, Eakin E, Maruyama NC. Health behavior changes after a cancer diagnosis: what do we know and where do we go from here? Ann Behav Med. 2000;22(1):38–52.CrossRefPubMed

14.

Kim RB, Phillips A, Herrick K, Helou M, Rafie C, Anscher MS, et al. Physical activity and sedentary behavior of cancer survivors and non-cancer individuals: results from a national survey. PLoS One. 2013;8(3):e57598. doi:10.1371/journal.pone.0057598.CrossRefPubMedPubMedCentral

15.

Milliron BJ, Vitolins MZ, Tooze JA. Usual dietary intake among female breast cancer survivors is not significantly different from women with no cancer history: results of the National Health and Nutrition Examination Survey, 2003-2006. J Acad Nutr Diet. 2014;114(6):932–7. doi:10.1016/j.jand.2013.08.015.CrossRefPubMed

16.

McBride CM, Clipp E, Peterson BL, Lipkus IM, Demark-Wahnefried W. Psychological impact of diagnosis and risk reduction among cancer survivors. Psycho-Oncology. 2000;9(5):418–27.CrossRef

17.

NICE. Managing overweight and obesity in adults – lifestyle weight management services. London: National Institute for Health and Care Excellence; 2014.

18.

Rabin C. Promoting lifestyle change among cancer survivors: when is the teachable moment? Am J Lifestyle Med. 2009;3(5):369-378

19.

Stacey FG, James EL, Chapman K, Courneya KS, Lubans DR. A systematic review and meta-analysis of social cognitive theory-based physical activity and/or nutrition behavior change interventions for cancer survivors. J Cancer Surviv. 2015;9(2):305–38. doi:10.1007/s11764-014-0413-z.CrossRefPubMed

20.

Adams RN, Mosher CE, Blair CK, Snyder DC, Sloane R, Demark-Wahnefried W. Cancer survivors’ uptake and adherence in diet and exercise intervention trials: An integrative data analysis. Cancer. 2014. doi:10.1002/cncr.28978.

21.

Weaver KE, Foraker RE, Alfano CM, Rowland JH, Arora NK, Bellizzi KM, et al. Cardiovascular risk factors among long-term survivors of breast, prostate, colorectal, and gynecologic cancers: a gap in survivorship care? J Cancer Surviv. 2013;7(2):253–61. doi:10.1007/s11764-013-0267-9.CrossRefPubMedPubMedCentral

22.

Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, et al. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012;30(19):2354–61. doi:10.1200/JCO.2011.40.0895.CrossRefPubMedPubMedCentral

23.

Mosher CE, Lipkus I, Sloane R, Snyder DC, Lobach DF, Demark-Wahnefried W. Long-term outcomes of the FRESH START trial: exploring the role of self-efficacy in cancer survivors’ maintenance of dietary practices and physical activity. Psycho-Oncology. 2013;22(4):876–85. doi:10.1002/pon.3089.CrossRefPubMed

24.

25.

Hawkes AL, Chambers SK, Pakenham KI, Patrao TA, Baade PD, Lynch BM, et al. 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;31(18):2313–21. doi:10.1200/JCO.2012.45.5873.CrossRefPubMed

26.

von Gruenigen V, Frasure H, Kavanagh MB, Janata J, Waggoner S, Rose P, et al. Survivors of uterine cancer empowered by exercise and healthy diet (SUCCEED): a randomized controlled trial. Gynecol Oncol. 2012;125(3):699–704. doi:10.1016/j.ygyno.2012.03.042.CrossRef

27.

von Gruenigen VE, Courneya KS, Gibbons HE, Kavanagh MB, Waggoner SE, Lerner E. Feasibility and effectiveness of a lifestyle intervention program in obese endometrial cancer patients: a randomized trial. Gynecol Oncol. 2008;109(1):19–26. doi:10.1016/j.ygyno.2007.12.026.CrossRef

28.

Department of Health. Quality of life of cancer survivors in England: Report on a pilot survey using Patient Reported Outcome Measures (PROMS) 2012.

29.

Reeves MM, Terranova CO, Eakin EG, Demark-Wahnefried W. Weight loss intervention trials in women with breast cancer: a systematic review. Obes Rev. 2014;15(9):749–68. doi:10.1111/obr.12190.CrossRefPubMed

30.

Millward DJ. Energy balance and obesity: a UK perspective on the gluttony v. sloth debate. Nutr Res Rev. 2013;26(2):89–109. doi:10.1017/S095442241300005X.CrossRefPubMed

31.

Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Bmj. 2013;346:e7586. doi:10.1136/bmj.e7586.

32.

Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. Bmj. 2014;348:g1687. doi:10.1136/bmj.g1687.

33.

Weight_Concern. Shape-Up programme. 2013. http://www.weightconcern.org.uk/node/31. Accessed 6 Oct 2014.

34.

Rapoport L, Clark M, Wardle J. Evaluation of a modified cognitive-behavioural programme for weight management. Int J Obes Relat Metab Disord. 2000;24(12):1726–37.CrossRefPubMed

35.

Bandura A. Health promotion by social cognitive means. Health Educ Behav. 2004;31(2):143–64. doi:10.1177/1090198104263660.CrossRefPubMed

36.

Carver CS, Scheier MF. Control theory: a useful conceptual framework for personality-social, clinical, and health psychology. Psychol Bull. 1982;92(1):111–35.CrossRefPubMed

37.

Department of Health, Obesity and Food Policy Branch, PHD. Developing a specification for lifestyle weight management services. London: Department of Health; 2013.

38.

NICE. Behaviour change: individual approaches. London: National Institute for Health and Care Excellence; 2014.

39.

Camden. Chapter 10: Obesity. London. 2013. http://www.camden.gov.uk/ccm/content/social-care-and-health/health-in-camden/joint-strategic-needs-assessment-2012/chapter-10-obesity-.en?page=6. Accessed 22 Oct 2014.

40.

Winters-Stone KM, Dobek J, Nail L, Bennett JA, Leo MC, Naik A, et al. Strength training stops bone loss and builds muscle in postmenopausal breast cancer survivors: a randomized, controlled trial. Breast Cancer Res Treat. 2011;127(2):447–56. doi:10.1007/s10549-011-1444-z.CrossRefPubMedPubMedCentral

41.

Hardee JP, Porter RR, Sui X, Archer E, Lee IM, Lavie CJ, et al. The Effect of Resistance Exercise on All-Cause Mortality in Cancer Survivors. Mayo Clin Proc. 2014. doi:10.1016/j.mayocp.2014.03.018

42.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M, et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi:10.1136/bmj.a1655.CrossRefPubMedPubMedCentral

43.

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649–55.CrossRefPubMed

44.

Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95. doi:10.1007/s12160-013-9486-6.CrossRefPubMed

45.

WCRF. Healthy living after cancer. World Cancer Research Fund. 2015. http://docs.wcrf.org/pdfs/healthy-living-after-cancer.pdf. Accessed 06 Aug 2015.

46.

Daley AJ, Crank H, Mutrie N, Saxton JM, Coleman R. Patient recruitment into a randomised controlled trial of supervised exercise therapy in sedentary women treated for breast cancer. Contemp Clin Trials. 2007;28(5):603–13. doi:10.1016/j.cct.2007.02.009.CrossRefPubMed

47.

Korde LA, Micheli A, Smith AW, Venzon D, Prindiville SA, Drinkard B, et al. Recruitment to a physical activity intervention study in women at increased risk of breast cancer. BMC Med Res Methodol. 2009;9:27. doi:10.1186/1471-2288-9-27.CrossRefPubMedPubMedCentral

48.

A’Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001;20(6):859–66. doi:10.1002/sim.721.CrossRefPubMed

49.

Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014;15:264. doi:10.1186/1745-6215-15-264.CrossRefPubMedPubMedCentral

50.

Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006;7(2):141–8. doi:10.1016/S1470-2045(06)70576-9.CrossRefPubMed

51.

Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005;330(7495):843. doi:10.1136/bmj.330.7495.843.CrossRefPubMedPubMedCentral

52.

DeSantis CE, Lin CC, Mariotto AB, Siegel RL, Stein KD, Kramer JL, et al. Cancer treatment and survivorship statistics, 2014. CA Cancer J Clin. 2014;64(4):252–71. doi:10.3322/caac.21235.CrossRefPubMed

53.

Saghaei M, Saghaei S. Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. J Biomed Sci Eng. 2011;4:734–9. doi:10.4236/jbise.2011.411090.CrossRef

54.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. 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(5):365–76.CrossRefPubMed

55.

Greimel E, Nordin A, Lanceley A, Creutzberg CL, van de Poll-Franse LV, Radisic VB, et al. Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). Eur J Cancer. 2011;47(2):183–90. doi:10.1016/j.ejca.2010.08.014.CrossRefPubMed

56.

Sallis JF, Haskell WL, Wood PD, Fortmann SP, Rogers T, Blair SN, et al. Physical activity assessment methodology in the Five-City Project. Am J Epidemiol. 1985;121(1):91–106.PubMed

57.

Bonnefoy M, Normand S, Pachiaudi C, Lacour JR, Laville M, Kostka T. Simultaneous validation of ten physical activity questionnaires in older men: a doubly labeled water study. J Am Geriatr Soc. 2001;49(1):28–35.CrossRefPubMed

58.

Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, et al. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012;112(8):1134–7. doi:10.1016/j.jand.2012.04.016.CrossRefPubMedPubMedCentral

59.

Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, et al. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012;142(6):1009–18. doi:10.3945/jn.111.157222.CrossRefPubMedPubMedCentral

60.

Roe L, Strong C, Whiteside C, Neil A, Mant D. Dietary intervention in primary care: validity of the DINE method for diet assessment. Fam Pract. 1994;11(4):375–81.CrossRefPubMed

61.

WHO. Waist Circumference and Waist-to-hip Ratio: Report of WHO Expert Consultation. Geneva: World Health Organisation. WHO Expert Consultation; 2008.

62.

Queensland_Health. Participant Satisfaction Survey. Queensland Government, Australia. 2014. http://www.health.qld.gov.au/stayonyourfeet/toolkits/phase4/tools-temp.asp. Accessed 19 Oct 2014.

63.

Gordon LG, Patrao T, Hawkes AL. Can colorectal cancer survivors recall their medications and doctor visits reliably? BMC Health Serv Res. 2012;12:440. doi:10.1186/1472-6963-12-440.CrossRefPubMedPubMedCentral

64.

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):337–43.CrossRefPubMed

65.

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. doi:10.1136/bmj.c869.CrossRefPubMedPubMedCentral

66.

Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011;71 Suppl 1:S52–63.CrossRefPubMedCentral

67.

International Committee of Medical Journal E. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Croat Med J. 2003;44(6):770–83.

68.

Grimmett C, Simon A, Lawson V, Wardle J. Diet and physical activity intervention in colorectal cancer survivors: A feasibility study. Eur J Oncol Nurs. 2014. doi:10.1016/j.ejon.2014.08.006

69.

Anderson AS, Caswell S, Wells M, Steele RJ, Macaskill S. “It makes you feel so full of life” LiveWell, a feasibility study of a personalised lifestyle programme for colorectal cancer survivors. Support Care Cancer. 2010;18(4):409–15. doi:10.1007/s00520-009-0677-4.CrossRefPubMed

70.

Department of Health, Macmillan Cancer Support & NHS Improvement. National Cancer Survivorship Initiative Vision. Department of Health, Macmillan Cancer Support & NHS Improvement, London 2010.

Title: Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial
Authors: Dimitrios A. Koutoukidis
Rebecca J. Beeken
Ranjit Manchanda
Matthew Burnell
M. Tish Knobf
Anne Lanceley
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1260-1

At a glance: The STEP trials

Springer Medicine

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial Registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial Registration

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