Factors influencing participation in a randomized controlled resistance exercise intervention study in breast cancer patients during radiotherapy

Sandra M Gollhofer, Joachim Wiskemann, Martina E Schmidt, Oliver Klassen, Cornelia M Ulrich, Jan Oelmann, Holger Hof, Karin Potthoff, Karen Steindorf, Sandra M Gollhofer, Joachim Wiskemann, Martina E Schmidt, Oliver Klassen, Cornelia M Ulrich, Jan Oelmann, Holger Hof, Karin Potthoff, Karen Steindorf

Abstract

Background: Over the past years knowledge about benefits of physical activity after cancer is evolving from randomized exercise intervention trials. However, it has been argued that results may be biased by selective participation. Therefore, we investigated factors influencing participation in a randomized exercise intervention trial for breast cancer patients.

Methods: Non-metastatic breast cancer patients were systematically screened for a randomized exercise intervention trial on cancer-related fatigue. Participants and nonparticipants were compared concerning sociodemographic characteristics (age, marital status, living status, travel time to the training facility), clinical data (body-mass-index, tumor stage, tumor size and lymph node status, comorbidities, chemotherapy), fatigue, and physical activity. Reasons for participation or declination were recorded.

Results: 117 patients (52 participants, 65 nonparticipants) were evaluable for analysis. Multiple regression analyses revealed significantly higher odds to decline participation among patients with longer travel time (p=0.0012), living alone (p=0.039), with more comorbidities (0.031), previous chemotherapy (p=0.0066), of age≥70 years (p=0.025), or being free of fatigue (p=0.0007). No associations were found with BMI or physical activity. By far the most frequently reported reason for declination of participation was too long commuting time to the training facility.

Conclusions: Willingness of breast cancer patients to participate in a randomized exercise intervention study differed by sociodemographic factors and health status. Neither current physical activity level nor BMI appeared to be selective for participation. Reduction of personal inconveniences and time effort, e.g. by decentralized training facilities or flexible training schedules, seem most promising for enhancing participation in exercise intervention trials.

Trial registration: Registered at ClinicalTrials.gov: NCT01468766 (October 2011).

Figures

Figure 1
Figure 1
Recruitment flow.

References

    1. Velthuis MJ, Agasi-Idenburg SC, Aufdemkampe G, Wittink HM. The effect of physical exercise on cancer-related fatigue during cancer treatment: a meta-analysis of randomised controlled trials. Clin Oncol (R Coll Radiol) 2010;22(3):208–21. doi: 10.1016/j.clon.2009.12.005.
    1. Berger AM, Gerber LH, Mayer DK. Cancer-related fatigue: implications for breast cancer survivors. Cancer. 2012;118(8 Suppl):2261–9. doi: 10.1002/cncr.27475.
    1. Jones LW, Alfano CM. Exercise-oncology research: Past, present, and future. Acta Oncol. 2013;52(2):195–215. doi: 10.3109/0284186X.2012.742564.
    1. Cramp F, James A, Lambert J. The effects of resistance training on quality of life in cancer: a systematic literature review and meta-analysis. Support Care Cancer. 2010;18(11):1367–76. doi: 10.1007/s00520-010-0904-z.
    1. Lakoski SG, Eves ND, Douglas PS, Jones LW. Exercise rehabilitation in patients with cancer. Nat Rev Clin Oncol. 2012;9(5):288–96. doi: 10.1038/nrclinonc.2012.27.
    1. van Dijk-Lokkart EM, Braam KI, Huisman J, Kaspers GJ, Takken T, Veening MA, et al. Factors influencing childhood cancer patients to participate in a combined physical and psychosocial intervention program: Quality of Life in Motion. Psychooncology. 2014; doi: 10.1002/pon.3677. [Epub ahead of print]
    1. 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. 2015;121(1):77–83. doi: 10.1002/cncr.28978.
    1. Dwan K, Gamble C, Williamson PR, Altman DG. Reporting of clinical trials: a review of research funders' guidelines. Trials. 2008;9:66. doi: 10.1186/1745-6215-9-66.
    1. Harrison JD, Solomon MJ, Young JM, Meagher A, Hruby G, Salkeld G, et al. Surgical and oncology trials for rectal cancer: who will participate? Surgery. 2007;142(1):94–101. doi: 10.1016/j.surg.2007.01.013.
    1. Gross CP, Mallory R, Heiat A, Krumholz HM. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med. 2002;137(1):10–6. doi: 10.7326/0003-4819-137-1-200207020-00007.
    1. Kemeny MM, Peterson BL, Kornblith AB, Muss HB, Wheeler J, Levine E, et al. Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol. 2003;21(12):2268–75. doi: 10.1200/JCO.2003.09.124.
    1. Elting LS, Cooksley C, Bekele BN, Frumovitz M, Avritscher EB, Sun C, et al. Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants. Cancer. 2006;106(11):2452–8. doi: 10.1002/cncr.21907.
    1. Simon MS, Du W, Flaherty L, Philip PA, Lorusso P, Miree C, et al. Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. J Clin Oncol. 2004;22(11):2046–52. doi: 10.1200/JCO.2004.03.005.
    1. Al-Refaie WB, Vickers SM, Zhong W, Parsons H, Rothenberger D, Habermann EB. Cancer trials versus the real world in the United States. Ann Surg. 2011;254(3):438–42. doi: 10.1097/SLA.0b013e31822a7047.
    1. Legge F, Eaton D, Molife R, Ferrandina G, Judson I, de Bono J, et al. Participation of patients with gynecological cancer in phase I clinical trials: two years experience in a major cancer center. Gynecol Oncol. 2007;104(3):551–6. doi: 10.1016/j.ygyno.2006.09.020.
    1. Courneya KS, Segal RJ, Mackey JR, Gelmon K, Reid RD, Friedenreich CM, et al. Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial. J Clin Oncol. 2007;25(28):4396–404. doi: 10.1200/JCO.2006.08.2024.
    1. de Jong Z, Munneke M, Jansen LM, Ronday K, van Schaardenburg DJ, Brand R, et al. Differences between participants and nonparticipants in an exercise trial for adults with rheumatoid arthritis. Arthritis Rheum. 2004;51(4):593–600. doi: 10.1002/art.20531.
    1. Potthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, et al. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer. 2013;13:162. doi: 10.1186/1471-2407-13-162.
    1. Steindorf K, Schmidt ME, Klassen O, Ulrich CM, Oelmann J, Habermann N, et al. Randomized, controlled trial of resistance training in breast cancer patients receiving adjuvant radiotherapy: results on cancer-related fatigue and quality of life. Ann Oncol. 2014;25(11):2237–43. doi: 10.1093/annonc/mdu374.
    1. Frey I, Berg A, Grathwohl D, Keul J. Freiburg Questionnaire of physical activity–development, evaluation and application. Soz Praventivmed. 1999;44(2):55–64. doi: 10.1007/BF01667127.
    1. Glaus A, Muller S. Measuring fatigue of cancer patients in the German-speaking region: development of the Fatigue Assessment Questionnaire. Pflege. 2001;14(3):161–70. doi: 10.1024/1012-5302.14.3.161.
    1. Beutel ME, Hinz A, Albani C, Brahler E. Fatigue assessment questionnaire: standardization of a cancer-specific instrument based on the general population. Oncology. 2006;70(5):351–7. doi: 10.1159/000098108.
    1. Frey I, Berg A. Körperliche Aktivität in Prävention und Therapie Evidenzbasierter Leitfaden für Klinik und Praxis. Hand Marseille Verlag GmbH, München: Samitz G., Mensink G.B.M; 2002.
    1. Cottin V, Arpin D, Lasset C, Cordier JF, Brune J, Chauvin F, et al. Small-cell lung cancer: patients included in clinical trials are not representative of the patient population as a whole. Ann Oncol. 1999;10(7):809–15. doi: 10.1023/A:1008399831512.
    1. Comis RL, Miller JD, Aldige CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21(5):830–5. doi: 10.1200/JCO.2003.02.105.
    1. Guidry JJ, Aday LA, Zhang D, Winn RJ. Transportation as a barrier to cancer treatment. Cancer Pract. 1997;5(6):361–6.
    1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720–6. doi: 10.1001/jama.291.22.2720.
    1. Hurria A. Clinical trials in older adults with cancer: past and future. Oncology (Williston Park) 2007;21(3):351–8.
    1. Mancini J, Geneve J, Dalenc F, Genre D, Monnier A, Kerbrat P, et al. Decision-making and breast cancer clinical trials: how experience challenges attitudes. Contemp Clin Trials. 2007;28(6):684–94. doi: 10.1016/j.cct.2007.03.001.
    1. Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000;82(11):1783–8. doi: 10.1054/bjoc.2000.1142.
    1. Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8(5):616–23. doi: 10.1177/1740774511414444.
    1. Catt S, Langridge C, Fallowfield L, Talbot DC, Jenkins V. Reasons given by patients for participating, or not, in Phase 1 cancer trials. Eur J Cancer. 2011;47(10):1490–7. doi: 10.1016/j.ejca.2011.02.020.
    1. Baggstrom MQ, Waqar SN, Sezhiyan AK, Gilstrap E, Gao F, Morgensztern D, et al. Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials. J Thorac Oncol. 2011;6(1):98–102. doi: 10.1097/JTO.0b013e3181fb50d8.
    1. Lara PN, Jr, Higdon R, Lim N, Kwan K, Tanaka M, Lau DH, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728–33.
    1. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143–56. doi: 10.1016/S0895-4356(99)00141-9.
    1. Locock L, Smith L. Personal benefit, or benefiting others? Deciding whether to take part in clinical trials. Clin Trials. 2011;8(1):85–93. doi: 10.1177/1740774510392257.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera