Control group design, contamination and drop-out in exercise oncology trials: a systematic review

Charlotte N Steins Bisschop, Kerry S Courneya, Miranda J Velthuis, Evelyn M Monninkhof, Lee W Jones, Christine Friedenreich, Elsken van der Wall, Petra H M Peeters, Anne M May, Charlotte N Steins Bisschop, Kerry S Courneya, Miranda J Velthuis, Evelyn M Monninkhof, Lee W Jones, Christine Friedenreich, Elsken van der Wall, Petra H M Peeters, Anne M May

Abstract

Purpose: Important considerations for exercise trials in cancer patients are contamination and differential drop-out among the control group members that might jeopardize the internal validity. This systematic review provides an overview of different control groups design characteristics of exercise-oncology trials and explores the association with contamination and drop-out rates.

Methods: Randomized controlled exercise-oncology trials from two Cochrane reviews were included. Additionally, a computer-aided search using Medline (Pubmed), Embase and CINAHL was conducted after completion date of the Cochrane reviews. Eligible studies were classified according to three control group design characteristics: the exercise instruction given to controls before start of the study (exercise allowed or not); and the intervention the control group was offered during (any (e.g., education sessions or telephone contacts) or none) or after (any (e.g., cross-over or exercise instruction) or none) the intervention period. Contamination (yes or no) and excess drop-out rates (i.e., drop-out rate of the control group minus the drop-out rate exercise group) were described according to the three design characteristics of the control group and according to the combinations of these three characteristics; so we additionally made subgroups based on combinations of type and timing of instructions received.

Results: 40 exercise-oncology trials were included based on pre-specified eligibility criteria. The lowest contamination (7.1% of studies) and low drop-out rates (excess drop-out rate -4.7±9.2) were found in control groups offered an intervention after the intervention period. When control groups were offered an intervention both during and after the intervention period, contamination (0%) and excess drop-out rates (-10.0±12.8%) were even lower.

Conclusions: Control groups receiving an intervention during and after the study intervention period have lower contamination and drop-out rates. The present findings can be considered when designing future exercise-oncology trials.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flowchart of included studies.
Fig 1. Flowchart of included studies.
Exercise oncology trials of the literature search between 19-4-2012 and 16-8-2013 and from two Cochrane reviews updated on 19-4-2012 and 1-6-2012. [1,2].

References

    1. Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev 2012;11: CD006145 10.1002/14651858.CD006145.pub3
    1. Fong DY, Ho JW, Hui BP Lee AM, Macfarlane DJ, Leung SS, et al. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ 2012;344: e70 10.1136/bmj.e70
    1. Mishra SI, Scherer RW, Snyder C, Geigle PM, Berlanstein DR, Topaloglu O. Exercise interventions on health-related quality of life for people with cancer during active treatment. Cochrane Database Syst Rev 2012;8: CD008465 10.1002/14651858.CD008465.pub2
    1. Courneya KS, Friedenreich CM, Quinney HA, Fields AL, jones LW, Fairey AS. A randomized trial of exercise and quality of life in colorectal cancer survivors. Eur J Cancer Care (Engl) 2003;12(4): 347–357.
    1. Courneya KS, Forbes CC, Trinh L, Sellar CM, Friedenreich CM, Reiman T. Patient satisfaction with participation in a randomized exercise trial: effects of randomization and a usual care posttrial exercise program. Clin Trials 2013;10(6): 959–966. 10.1177/1740774513495985
    1. Hertogh EM, Schuit AJ, Peeters PH, Monninkhof EM. Noncompliance in lifestyle intervention studies: the instrumental variable method provides insight into the bias. J Clin Epidemiol 2010;63(8): 900–906. 10.1016/j.jclinepi.2009.10.007
    1. Waters L, Reeves M, Fjeldsoe B, Eakin E. Control group improvements in physical activity intervention trials and possible explanatory factors: a systematic review. J Phys Act Health 2012;9(6): 884–895.
    1. Mock V, Frangakis C, Davidson NE, Ropka ME, Pickett M, Poniatowski B, et al. Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. Psychooncology 2005;14(6): 464–477.
    1. Adamsen L, Quist M, Andersen C, Moller T, Herrstedt J, Kronborg D, et al. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial. BMJ 2009;339: b3410 10.1136/bmj.b3410
    1. 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(2): 229–234. 10.1016/j.lungcan.2010.04.025
    1. Broderick JM, Guinan E, Kennedy MJ, Hollywood D, Courneya KS, Culos-Reed SN, et al. Feasibility and efficacy of a supervised exercise intervention in de-conditioned cancer survivors during the early survivorship phase: the PEACH trial. J Cancer Surviv 2013;7(4): 551–562. 10.1007/s11764-013-0294-6
    1. Cadmus LA, Salovey P, Yu H, Chung G, Kasl S, Irwin ML. Exercise and quality of life during and after treatment for breast cancer: results of two randomized controlled trials. Psychooncology 2009;18(4): 343–352. 10.1002/pon.1525
    1. Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol 2003;21(9): 1660–1668.
    1. Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology 2003;12(4): 357–374.
    1. Courneya KS, Segal RJ, Mackey JR, Gelmon K, Reid RD, Friedenreich CM. Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial. J Clin Oncol 2007;25(28): 4396–4404.
    1. Courneya KS, Jones LW, Peddle CJ, Sellar CM, Reiman T, Joy AA, et al. Effects of aerobic exercise training in anemic cancer patients receiving darbepoetin alfa: a randomized controlled trial. Oncologist 2008;13(9): 1012–1020. 10.1634/theoncologist.2008-0017
    1. Courneya KS, Sellar CM, Stevinson C, McNeely ML, Peddle CJ, Friedenreich CM, et al. Randomized controlled trial of the effects of aerobic exercise on physical functioning and quality of life in lymphoma patients. J Clin Oncol 2009;27(27): 4605–4612. 10.1200/JCO.2008.20.0634
    1. Daley AJ, Crank H, Saxton JM, Mutrie N, Coleman R, Roalfe A. Randomized trial of exercise therapy in women treated for breast cancer. J Clin Oncol 2007;25(13): 1713–1721.
    1. Dimeo FC, Thomas F, Raabe-Menssen C, Propper F, Mathias M. Effect of aerobic exercise and relaxation training on fatigue and physical performance of cancer patients after surgery. A randomised controlled trial. Support Care Cancer 2004;12(11): 774–779.
    1. Dodd MJ, Cho MH, Miaskowski C, Painter PL, Paul SM, Cooper BA, et al. A randomized controlled trial of home-based exercise for cancer-related fatigue in women during and after chemotherapy with or without radiation therapy. Cancer Nurs 2010;33(4): 245–257. 10.1097/NCC.0b013e3181ddc58c
    1. Ergun M, Eyigor S, Karaca B, Kisim A, Uslu R. Effects of exercise on angiogenesis and apoptosis-related molecules, quality of life, fatigue and depression in breast cancer patients. Eur J Cancer Care (Engl) 2013;22(5): 626–637. 10.1111/ecc.12068
    1. Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Combined resistance and aerobic exercise program reverses muscle loss in men undergoing androgen suppression therapy for prostate cancer without bone metastases: a randomized controlled trial. J Clin Oncol 2010;28(2): 340–347. 10.1200/JCO.2009.23.2488
    1. Galvao DA, Spry N, Denham J, Taaffe DR, Cormie P, Joseph D, et al. A multicentre year-long randomised controlled trial of exercise training targeting physical functioning in men with prostate cancer previously treated with androgen suppression and radiation from TROG 03.04 RADAR. Eur Urol 2014;65(5): 856–864. 10.1016/j.eururo.2013.09.041
    1. Griffith K, Wenzel J, Shang J, Thompson C, Stewart K, Mock V. Impact of a walking intervention on cardiorespiratory fitness, self-reported physical function, and pain in patients undergoing treatment for solid tumors. Cancer 2009;115(20): 4874–4884. 10.1002/cncr.24551
    1. Hayes SC, Rye S, Disipio T, Yates P, Bashford J, Pyke C. Exercise for health: a randomized, controlled trial evaluating the impact of a pragmatic, translational exercise intervention on the quality of life, function and treatment-related side effects following breast cancer. Breast Cancer Res Treat 2013;137(1): 175–186. 10.1007/s10549-012-2331-y
    1. Jacobsen PB, Phillips KM, Jim HS, Small BJ, Faul LA, Meade CD, et al. Effects of self-directed stress management training and home-based exercise on quality of life in cancer patients receiving chemotherapy: a randomized controlled trial. Psychooncology 2013;22(6): 1229–1235. 10.1002/pon.3122
    1. Kwiatkowski F, Mouret-Reynier MA, Duclos M, Leger-Enreille A, Bridon F, Hahn T. Long term improved quality of life by a 2-week group physical and educational intervention shortly after breast cancer chemotherapy completion. Results of the 'Programme of Accompanying women after breast Cancer treatment completion in Thermal resorts' (PACThe) randomised clinical trial of 251 patients. Eur J Cancer 2013;49(7): 1530–1538. 10.1016/j.ejca.2012.12.021
    1. Lin KY, Shun SC, Lai YH, Liang JT, Tsauo JY. Comparison of the effects of a supervised exercise program and usual care in patients with colorectal cancer undergoing chemotherapy. Cancer Nurs 2014;37(2): E21–E29. 10.1097/NCC.0b013e3182791097
    1. McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, et al. Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivors: a randomized controlled trial. Cancer 2008;113(1): 214–222. 10.1002/cncr.23536
    1. Milne HM, Wallman KE, Gordon S, Courneya KS. Effects of a combined aerobic and resistance exercise program in breast cancer survivors: a randomized controlled trial. Breast Cancer Res Treat 2008;108(2): 279–288.
    1. Mutrie N, Campbell AM, Whyte F, McConnachie A, Emslie C, Lee L, et al. Benefits of supervised group exercise programme for women being treated for early stage breast cancer: pragmatic randomised controlled trial. BMJ 2007;334(7592): 517
    1. Saarto T, Penttinen HM, Sievanen H, Kellokumpu-Lehtinen PL, Hakamies-Blomqvist L, Nikander R, et al. Effectiveness of a 12-month exercise program on physical performance and quality of life of breast cancer survivors. Anticancer Res 2012;32(9): 3875–3884.
    1. Samuel SR, Maiya GA, Babu AS, Vidyasagar MS. Effect of exercise training on functional capacity & quality of life in head & neck cancer patients receiving chemoradiotherapy. Indian J Med Res 2013;137(3): 515–520.
    1. Segal R, Evans W, Johnson D, Smith J, Colletta S, Gayton J, et al. Structured exercise improves physical functioning in women with stages I and II breast cancer: results of a randomized controlled trial. J Clin Oncol 2001;19(3): 657–665.
    1. Segal RJ, Reid RD, Courneya KS, Malone SC, Parliament MB, Scott CG, et al. Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol 2003;21(9): 1653–1659.
    1. Segal RJ, Reid RD, Courneya KS, Segal RJ, Kenny GP, Prud'Homme DG, et al. Randomized controlled trial of resistance or aerobic exercise in men receiving radiation therapy for prostate cancer. J Clin Oncol 2009;27(3): 344–351. 10.1200/JCO.2007.15.4963
    1. Tang MF, Liou TH, Lin CC. Improving sleep quality for cancer patients: benefits of a home-based exercise intervention. Support Care Cancer 2010;18(10): 1329–1339. 10.1007/s00520-009-0757-5
    1. Thorsen L, Skovlund E, Stromme SB, Hornslien K, Dahl AA, Fossa SDl. Effectiveness of physical activity on cardiorespiratory fitness and health-related quality of life in young and middle-aged cancer patients shortly after chemotherapy. J Clin Oncol 2005;23(10): 2378–2388.
    1. Wang YJ, Boehmke M, Wu YW, Dickerson SS, Fisher N. Effects of a 6-week walking program on Taiwanese women newly diagnosed with early-stage breast cancer. Cancer Nurs 2011;34(2): E1–13. 10.1097/NCC.0b013e3181e4588d
    1. Windsor PM, Nicol KF, Potter J. A randomized, controlled trial of aerobic exercise for treatment-related fatigue in men receiving radical external beam radiotherapy for localized prostate carcinoma. Cancer 2004;101(3): 550–557.
    1. Wiskemann J, Dreger P, Schwerdtfeger R, Bondong A, Huber G, Kleindienst N, et al. Effects of a partly self-administered exercise program before, during, and after allogeneic stem cell transplantation. Blood 2011;117(9): 2604–2613. 10.1182/blood-2010-09-306308
    1. Yang CY, Tsai JC, Huang YC, Lin CC. Effects of a home-based walking program on perceived symptom and mood status in postoperative breast cancer women receiving adjuvant chemotherapy. J Adv Nurs 2011;67(1): 158–168. 10.1111/j.1365-2648.2010.05492.x
    1. Shang J, Wenzel J, Krumm S, Griffith K, Stewart K. Who will drop out and who will drop in: exercise adherence in a randomized clinical trial among patients receiving active cancer treatment. Cancer Nurs 2012;35(4): 312–322. 10.1097/NCC.0b013e318236a3b3
    1. Velthuis MJ, May AM, Monninkhof EM van der Wall E, Peeters PH. Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization. J Clin Epidemiol 2012;65(3): 288–292. 10.1016/j.jclinepi.2011.03.015
    1. Hernan MA, Hernandez-Diaz S. Beyond the intention-to-treat in comparative effectiveness research. Clin Trials 2012;9(1): 48–55. 10.1177/1740774511420743
    1. Little RJ, Long Q, Lin X. A comparison of methods for estimating the causal effect of a treatment in randomized clinical trials subject to noncompliance. Biometrics 2009;65(2): 640–649. 10.1111/j.1541-0420.2008.01066.x
    1. Dunn G, Maracy M, Tomenson B. Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods. Stat Methods Med Res 2005;14(4): 369–395.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться