Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer--a randomized controlled trial

Anna M Sawka, Sharon Straus, James D Brierley, Richard W Tsang, Lorne Rotstein, Gary Rodin, Amiram Gafni, Shereen Ezzat, Lehana Thabane, Kevin E Thorpe, David P Goldstein, Anna M Sawka, Sharon Straus, James D Brierley, Richard W Tsang, Lorne Rotstein, Gary Rodin, Amiram Gafni, Shereen Ezzat, Lehana Thabane, Kevin E Thorpe, David P Goldstein

Abstract

Background: Patients with early stage papillary thyroid carcinoma (PTC), are faced with the decision to either to accept or reject adjuvant radioactive iodine (RAI) treatment after thryroidectomy. This decision is often difficult because of conflicting reports of RAI treatment benefit and medical evidence uncertainty due to the lack of long-term randomized controlled trials.

Methods: We report the protocol for a parallel, 2-arm, randomized trial comparing an intervention group exposed to a computerized decision aid (DA) relative to a control group receiving usual care. The DA explains the options of adjuvant radioactive iodine or no adjuvant radioactive iodine, as well as associated potential benefits, risks, and follow-up implications. Potentially eligible adult PTC patient participants will include: English-speaking individuals who have had recent thyroidectomy, and whose primary tumor was 1 to 4 cm in diameter, with no known metastases to lymph nodes or distant sites, with no other worrisome features, and who have not received RAI treatment for thyroid cancer. We will measure the effect of the DA on the following patient outcomes: a) knowledge about PTC and RAI treatment, b) decisional conflict, c) decisional regret, d) client satisfaction with information received about RAI treatment, and e) the final decision to accept or reject adjuvant RAI treatment and rationale.

Discussion: This trial will provide evidence of feasibility and efficacy of the use of a computerized DA in explaining complex issues relating to decision making about adjuvant RAI treatment in early stage PTC.

Trial registration: Clinical Trials.gov Identifier: NCT01083550.

Figures

Figure 1
Figure 1
Overview of the study. PTC: papillary thyroid cancer, RAI: radioactive iodine.

References

    1. Liu S, Semenciw R, Ugnat AM, Mao Y. Increasing thyroid cancer incidence in Canada, 1970-1996: time trends and age-period-cohort effects. Br J Cancer. 2001;85:1335–1339. doi: 10.1054/bjoc.2001.2061.
    1. Edwards BK, Howe HL, Ries LA, Thun MJ, Rosenberg HM, Yancik R, Wingo PA, Jemal A, Feigal EG. Annual report to the nation on the status of cancer, 1973-1999, featuring implications of age and aging on U.S. cancer burden. Cancer. 2002;94(10):2766–2792. doi: 10.1002/cncr.10593.
    1. Davies L, Welch HG. Increasing incidence of thyroid cancer in the United States. JAMA. 2006;295:2164–2167. doi: 10.1001/jama.295.18.2164.
    1. Colonna M, Grosclaude P, Remontet L, Schvartz C, Mace-Lesech J, Velten M, Guizard A, Tretarre B, Buemi AV, Arveux P, Esteve J. Incidence of thyroid cancer in adults recorded by French cancer registries (1978-1997) Eur J Cancer. 2002;38:1762–1768. doi: 10.1016/S0959-8049(02)00110-7.
    1. Dos Santos Silva I, Swerdlow AJ. Thyroid cancer epidemiology in England and Wales: Time trends and geographical distribution. Br J Cancer. 1993;67:330–340.
    1. Park SH, Suh EH, Chi JG. A histopathologic study on 1,095 surgically resected thyroid specimens. Jpn J Clin Oncol. 1988;18(4):297–302.
    1. Hay ID, McConahey WM, Goellner JR. Managing patients with papillary thyroid carcinoma: Insights gained from the Mayo Clinic's experience of treating 2,512 consecutive patients during 1940 through 2000. Trans Am Clin Climatol Assoc. 2002;113:241–260.
    1. American Thyroid Association (ATA) Guidelines Taskforce on Thyroid Nodules and Differentiated Thyroid Cancer. Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, Mazzaferri EL, McIver B, Pacini F, Schlumberger M, Sherman SI, Steward DL, Tuttle RM. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19:1167–214. doi: 10.1089/thy.2009.0110.
    1. Pacini F, Schlumberger M, Dralle H, Elisei R, Smit JWA, Wiersinga W. the European Thyroid Cancer Task Force. European consensus for the management of patients with differentiated thyroid carcinoma of the follicular epithelium. Eur J of Endo. 2006;154:787–803. doi: 10.1530/eje.1.02158.
    1. British Thyroid Association; Royal College of Physicians. Guidelines for the management of thyroid cancer. Second. 2007. Accessed December 14, 2009.
    1. Sawka AM, Brierley JD, Tsang RW, Thabane L, Rotstein L, Gafni A, Straus S, Goldstein DP. An updated systematic review and commentary examining the effectiveness of radioactive iodine remnant ablation in well-differentiated thyroid cancer. Endocrinol Metab Clin North Am. 2008;37(2):457–80. doi: 10.1016/j.ecl.2008.02.007.
    1. Sawka AM, Goldstein DP, Brierley JD, Tsang RW, Rotstein L, Ezzat S, Straus S, George SR, Abbey S, Rodin G, O'Brien MA, Gafni A, Thabane L, Goguen J, Naeem A, Magalhaes L. The impact of thyroid cancer and post-surgical radioactive iodine treatment on the lives of thyroid cancer survivors: A qualitative study. Plos One. 2009;4(1):e4191. doi: 10.1371/journal.pone.0004191.
    1. O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner D. Decision aids for people facing health treatment or screening decisions. Cochrane Database of Systematic Reviews. 2009. p. CD001431.
    1. American Joint Committee on Cancer. AJCC Cancer Staging Manual. 6. New York: Springer; 2002.
    1. Sawka AM, Lakra DC, Lea J, Alshehri B, Tsang RW, Brierley JD, Straus S, Thabane L, Gafni A, Ezzat S, George SR, Goldstein DP. A systematic review examining the effects of therapeutic radioactive iodine on ovarian function and future pregnancy in female thyroid cancer survivors. Clin Endocrinol (Oxf) 2008;69:479–480. doi: 10.1111/j.1365-2265.2008.03222.x.
    1. Sawka AM, Lea J, Alshehri B, Straus S, Tsang RW, Brierley JD, Thabane L, Rotstein L, Gafni A, Ezzat S, Goldstein DP. A systematic review of the gonadal effects of therapeutic radioactive iodine in male thyroid cancer survivors. Clin Endocrinol (Oxf) 2008;68(4):610–7. doi: 10.1111/j.1365-2265.2007.03081.x.
    1. Sawka AM, Thabane L, Parlea L, Ibrahim-zada I, Tsang RW, Brierley JD, Straus S, Ezzat S, Goldstein DP. Second primary malignancy risk after radioactive iodine treatment for thyroid cancer: A systematic review and meta-analysis. Thyroid. 2009;19:451–457. doi: 10.1089/thy.2008.0392.
    1. Miller SM. Monitoring and blunting: Validation of a questionnaire to assess styles of information seeking under threat. J Pers Soc Psychol. 1987;52(2):345–353. doi: 10.1037/0022-3514.52.2.345.
    1. O'Connor AM. User Manual - Decisional Conflict Scale. 1993. Accessed July 23, 2010, updated 2005.
    1. O'Connor AM. Validation of a decisional conflict scale. Med Dec Making. 1995;15:25–30. doi: 10.1177/0272989X9501500105.
    1. Larsen DL, Attkisson C, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: Development of a general scale. Eval Program Plann. 1979;2:197–207. doi: 10.1016/0149-7189(79)90094-6.
    1. O'Connor AM. User Manual - Decision Regret Scale. 1996. Accessed July 23, 2010, updated 2003.
    1. Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Medical Decis Making. 2003;23(4):281–292. doi: 10.1177/0272989X03256005.
    1. Glaser BG, Strauss AL. The discovery of grounded theory: strategies for qualitative research. Chicago: Aldine; 1967.
    1. Finlay L. Outing the researcher: The provenance, process, and practice of reflexivity. Qual Res Methods. 2002;12:531–545.
    1. Denzin LL, Lincoln YS. The Sage Handbook of Qualitative Research. 3. Sage Publications: Newbury Park, California: Sage Publications; 2005. p. 1230.
    1. Lottridge DM, Chignell M, Danicic-Mizdrak R, Pavlovic NJ, Kushniruk A, Straus SE. Group differences in physician responses to handheld presentation of clinical evidence: A verbal protocol analysis. BMS Med Inform Decis Mak. 2007;26:7–22.
    1. Sandelowski M. Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Res Nurs Health. 2000;23(3):246–155. doi: 10.1002/1098-240X(200006)23:3<246::AID-NUR9>;2-H.
    1. Voils CI, Sandelowski M, Barroso J, Hasselblad V. Making Sense of Qualitative and Quantitative Findings in Mixed Research Synthesis Studies. Field Methods. 2008;20(1):3–25. doi: 10.1177/1525822X07307463.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren