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BMC Medical Informatics and Decision Making
Published in: BMC Medical Informatics and Decision Making 1/2019

Open Access 01-12-2019 | Mastectomy | Study protocol

The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: study protocol of a multicenter randomized controlled trial

Authors: Jacqueline A. ter Stege, Leonie A. E. Woerdeman, Daniela E. E. Hahn, Martine A. van Huizum, Frederieke H. van Duijnhoven, Jacobien M. Kieffer, Valesca P. Retèl, Kerry A. Sherman, Arjen J. Witkamp, Hester S. A. Oldenburg, Eveline M. A. Bleiker

Published in: BMC Medical Informatics and Decision Making | Issue 1/2019

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Abstract

Background

Most breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA’s impact on health outcomes, explore predictors, and assess its cost-effectiveness.

Methods

A multicenter, two-armed randomized controlled trial (1:1) will be conducted. Women with breast cancer or ductal carcinoma in situ who will undergo a mastectomy and are eligible for immediate breast reconstruction will be invited to participate. The intervention group will receive access to the online pDA, whereas the control group will receive a widely available free information leaflet on breast reconstruction. Participants will complete online questionnaires at: baseline (T0), 1 week after consultation with a plastic surgeon (T1), and 3 (T2) and 12 months (T3) after surgery. The primary outcome is decisional conflict. Secondary outcomes include other measures reflecting the decision-making process and decision quality (e.g., decision regret), patient-reported health outcomes (e.g., satisfaction with the breasts) and costs.

Discussion

This study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision.

Trial registration

This study is retrospectively registered at ClinicalTrials.gov (NCT03791138).
Literature
1.
2.
3.
Curado MP, Edwards B, Shin HR, Storm H, Ferlay J, Heanue M, et al. Cancer incidence in five continents, volume IX. Lyon: IARC Press, International Agency for Research on Cancer; 2007.
4.
Jeevan R, Cromwell DA, Browne JP, Caddy CM, Pereira J, Sheppard C, et al. Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg. 2014;67(10):1333–44.PubMedCrossRef
5.
Roder D, Zorbas H, Kollias J, Pyke C, Walters D, Campbell I, et al. Factors predictive of immediate breast reconstruction following mastectomy for invasive breast cancer in Australia. Breast. 2013;22(6):1220–5.PubMedCrossRef
6.
National Breast and Ovarian Cancer Centre. National Breast and Ovarian Cancer Centre and Royal Australasian College of Surgeons National Breast Cancer Audit Public Health Monitoring Series 2008 Data. Surry Hills: National Breast and Ovarian Cancer Centre; 2010.
7.
8.
Parker PA, Youssef A, Walker S, Basen-Engquist K, Cohen L, Gritz ER, et al. Short-term and long-term psychosocial adjustment and quality of life in women undergoing different surgical procedures for breast cancer. Ann Surg Oncol. 2007;14(11):3078–89.PubMedCrossRef
9.
10.
Janni W, Rjosk D, Dimpfl T, Haertl K, Strobl B, Hepp F, et al. Quality of life influenced by primary surgical treatment for stage I-III breast cancer-long-term follow-up of a matched-pair analysis. Ann Surg Oncol. 2001;8(6):542–8.PubMed
11.
Chen CL, Liao MN, Chen SC, Chan PL, Chen SC. Body image and its predictors in breast cancer patients receiving surgery. Cancer Nurs. 2012;35(5):E10–6.PubMedCrossRef
12.
Lee GK, Sheckter CC. Breast reconstruction following breast cancer treatment-2018. JAMA. 2018;320(12):1277–8.PubMedCrossRef
13.
14.
Panchal H, Matros E. Current trends in postmastectomy breast reconstruction. Plast Reconstr Surg. 2017;140(5S Advances in Breast Reconstruction):7s–13s.PubMedPubMedCentralCrossRef
15.
Mennie JC, Mohanna PN, O’Donoghue JM, Rainsbury R, Cromwell DA. National trends in immediate and delayed post-mastectomy reconstruction procedures in England: a seven-year population-based cohort study. Eur J Surg Oncol. 2017;43(1):52–61.PubMedCrossRef
16.
17.
Sheehan J, Sherman KA, Lam T, Boyages J. Association of information satisfaction, psychological distress and monitoring coping style with post-decision regret following breast reconstruction. Psychooncology. 2007;16:342–51.PubMedCrossRef
18.
Dikmans REG, van de Grift TC, Bouman MB, Pusic AL, Mullender MG. Sexuality, a topic that surgeons should discuss with women before risk-reducing mastectomy and breast reconstruction. Breast. 2019;43:120–2.PubMedCrossRef
19.
Kuo NT, Kuo YL, Lai HW, Ko NY, Fang SY. The influence of partner involvement in the decision-making process on body image and decision regret among women receiving breast reconstruction. Support Care Cancer. 2019;27(5):1721–8.PubMedCrossRef
20.
Lee CN, Pignone MP, Deal AM, Blizard L, Hunt C, Huh R, et al. Accuracy of predictions of patients with breast cancer of future well-being after immediate breast reconstruction. JAMA Surg. 2018;153(4):e176112.PubMedPubMedCentralCrossRef
21.
Hasak JM, Myckatyn TM, Grabinski VF, Philpott SE, Parikh RP, Politi MC. Stakeholders’ perspectives on postmastectomy breast reconstruction: recognizing ways to improve shared decision making. Plast Reconstr Surg Glob Open. 2017;5(11):e1569.PubMedPubMedCentralCrossRef
22.
Zhong T, Hu J, Bagher S, O'Neill AC, Beber B, Hofer SO, et al. Decision regret following breast reconstruction: the role of self-efficacy and satisfaction with information in the preoperative period. Plast Reconstr Surg. 2013;132(5):724e–34e.PubMedCrossRef
23.
Potter S, Mills N, Cawthorn S, Wilson S, Blazeby J. Exploring information provision in reconstructive breast surgery: a qualitative study. Breast. 2015;24(6):732–8.PubMedCrossRef
24.
Soon PS, Ruban S, Mo HTJ, Lee R, Saliba L, Shah A, et al. Understanding patient choices regarding breast reconstruction after mastectomy for breast cancer. Support Care Cancer. 2019;27(6):2135–42.PubMedCrossRef
25.
Flitcroft K, Brennan M, Spillane A. Decisional regret and choice of breast reconstruction following mastectomy for breast cancer: a systematic review. Psychooncology. 2018;27(4):1110–20.PubMedCrossRef
26.
Zhong T, Bagher S, Jindal K, Zeng D, O'Neill AC, MacAdam S, et al. The influence of dispositional optimism on decision regret to undergo major breast reconstructive surgery. J Surg Oncol. 2013;108(8):526–30.PubMedCrossRef
27.
Manne SL, Topham N, Kirstein L, Virtue SM, Brill K, Devine KA, et al. Attitudes and decisional conflict regarding breast reconstruction among breast cancer patients. Cancer Nurs. 2016;39(6):427–36.PubMedCrossRef
28.
Fallbjörk U, Frejeus E, Rasmussen BH. A preliminary study into women's experiences of undergoing reconstructive surgery after breast cancer. Eur J Oncol Nurs. 2012;16(3):220–6.PubMedCrossRef
29.
Murray CD, Turner A, Rehan C, Kovacs T. Satisfaction following immediate breast reconstruction: experiences in the early post-operative stage. Br J Health Psychol. 2015;20(3):579–93.PubMedCrossRef
30.
Lee CN, Deal AM, Huh R, Ubel PA, Liu YJ, Blizard L, et al. Quality of patient decisions about breast reconstruction after mastectomy. JAMA Surg. 2017;152(8):741–8.PubMedPubMedCentralCrossRef
31.
Joseph-Williams N, Newcombe R, Politi M, Durand MA, Sivell S, Stacey D, et al. Toward minimum standards for certifying patient decision aids: a modified delphi consensus process. Med Decis Mak. 2014;34(6):699–710.CrossRef
32.
Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Systemat Rev. 2017;4:Cd001431.
33.
Sheehan J, Sherman KA. Computerised decision aids: a systematic review of their effectiveness in facilitating high-quality decision-making in various health-related contexts. Patient Educ Couns. 2012;88(1):69–86.PubMedCrossRef
34.
Paraskeva N, Guest E, Lewis-Smith H, Harcourt D. Assessing the effectiveness of interventions to support patient decision making about breast reconstruction: a systematic review. Breast. 2018;40:97–105.PubMedCrossRef
35.
Lam WW, Chan M, Or A, Kwong A, Suen D, Fielding R. Reducing treatment decision conflict difficulties in breast cancer surgery: a randomized controlled trial. J Clin Oncol. 2013;31(23):2879–85.PubMedCrossRef
36.
Sherman KA, Shaw LK, Winch CJ, Harcourt D, Boyages J, Cameron LD, et al. Reducing decisional conflict and enhancing satisfaction with information among women considering breast reconstruction following mastectomy: results from the BRECONDA randomized controlled trial. Plast Reconstr Surg. 2016;138(4):592e–602e.PubMedCrossRef
37.
Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, et al. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015;23(5):1365–75.PubMedCrossRef
38.
Luan A, Hui KJ, Remington AC, Liu X, Lee GK. Effects of a novel decision aid for breast reconstruction: a randomized prospective trial. Ann Plast Surg. 2016;76(Suppl 3):S249–54.PubMedCrossRef
39.
Heller L, Parker PA, Youssef A, Miller MJ. Interactive digital education aid in breast reconstruction. Plast Reconstr Surg. 2008;122(3):717–24.PubMedCrossRef
40.
Sherman KA, Harcourt DM, Lam TC, Shaw LK, Boyages J. BRECONDA: development and acceptability of an interactive decisional support tool for women considering breast reconstruction. Psychooncology. 2014;23(7):835–8.PubMedCrossRef
41.
Sherman KA, Shaw LK, Jørgensen L, Harcourt D, Cameron L, Boyages J, et al. Qualitatively understanding patients’ and health professionals’ experiences of the BRECONDA breast reconstruction decision aid. Psychooncology. 2017;26(10):1618–24.PubMedCrossRef
42.
Elwyn G, O’Connor AM, Bennett C, Newcombe RG, Politi M, Durand MA, et al. Assessing the quality of decision support technologies using the international patient decision aid standards instrument (IPDASi). PLoS One. 2009;4(3):e4705.PubMedPubMedCentralCrossRef
43.
Netherlands Patients Federation, Dutch College of General Practitioners, Royal Dutch Medical Association, Dutch Professional Nurses Organisation (2018). Guideline decision aid with guidelines [in Dutch].
44.
45.
Council of Europe. Common European framework of reference for languages: learning, teaching, assessment. 1st ed. Cambridge: Cambridge University Press; 2001.
46.
O'Connor AM. Validation of a decisional conflict scale. Med Decis Mak. 1995;15(1):25–30.CrossRef
47.
48.
Koedoot N, Molenaar S, Oosterveld P, Bakker P, de Graeff A, Nooy M, et al. The decisional conflict scale: further validation in two samples of Dutch oncology patients. Patient Educ Couns. 2001;45(3):187–93.PubMedCrossRef
49.
Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009;124(2):345–53.PubMedCrossRef
50.
51.
Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010;78(1):130–3.PubMedCrossRef
52.
Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item shared decision making questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010;80(1):94–9.PubMedCrossRef
53.
Rodenburg-Vandenbussche S, Pieterse AH, Kroonenberg PM, Scholl I, van der Weijden T, Luyten GP, et al. Dutch translation and psychometric testing of the 9-item shared decision making questionnaire (SDM-Q-9) and shared decision making questionnaire-physician version (SDM-Q-doc) in primary and secondary care. PLoS One. 2015;10(7):e0132158.PubMedPubMedCentralCrossRef
54.
Degner LF, Sloan JA, Venkatesh P. The control preferences scale. Can J Nurs Res. 1997;29(3):21–43.PubMed
55.
Sherman KA, Kilby CJ, Shaw LK, Winch C, Kirk J, Tucker K, et al. Facilitating decision-making in women undergoing genetic testing for hereditary breast cancer: BRECONDA randomized controlled trial results. Breast. 2017;36:79–85.PubMedCrossRef
56.
Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a decision regret scale. Med Decis Mak. 2003;23(4):281–92.CrossRef
57.
58.
Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, et al. The European organization for research and treatment of cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996;14(10):2756–68.PubMedCrossRef
59.
Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger state-trait anxiety inventory (STAI). Br J Clin Psychol. 1992;31(Pt 3):301–6.PubMedCrossRef
60.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208.CrossRef
61.
O’Connor AM. Decisional conflict. In: GK MF, EA MF, editors. Nursing: Diagnosis and Intervention. 2nd ed. St. Lois: Mosby; 1993. p. 468Y77.
62.
Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, et al. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13(Suppl 2):S12.PubMedPubMedCentralCrossRef
63.
van Zuuren FJ, de Groot KI, Mulder NL, Muris P. Coping with medical threat: an evaluation of the threatening medical situations inventory (TMSI). Pers Individ Dif. 1996;21(1):21–31.CrossRef
64.
65.
Hakkaart-van Roijen L, Van der Linden N, Bouwmans CAM, Kanters T, Tan SS. Costing manual: methodology of costing research and reference prices for economic evaluations in healthcare [in Dutch]; 2015.
66.
Diggle PJ, Heagerty P, Liang KY, Zeger, SL. Analysis of Longitudinal Data. 2nd ed. New York: Oxford University Press; 2002, pp 169–189.
67.
Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale: Lawrence Erlbaum Associates; 1998.
68.
Paolo Ghisletta, Dario Spini. An Introduction to Generalized Estimating Equations and an Application to Assess Selectivity Effects in a Longitudinal Study on Very Old Individuals. J Educ Behav Stat. 2016;29 (4):421–437.CrossRef
69.
Ivy Liu, Alan Agresti. The analysis of ordered categorical data: An overview and a survey of recent developments. Test. 2005;14(1):1–73.CrossRef
70.
Becerra Perez MM, Menear M, Brehaut JC, Légaré F. Extent and predictors of decision regret about health care decisions: a systematic review. Med Decis Mak. 2016;36(6):777–90.CrossRef
71.
Lalonde L, O'Connor AM, Duguay P, Brassard J, Drake E, Grover SA. Evaluation of a decision aid and a personal risk profile in community pharmacy for patients considering options to improve cardiovascular health: the OPTIONS pilot study. Int J Pharm Pract. 2006;14:51–62.CrossRef
72.
73.
Labrecque M, Paunescu C, Plesu I, Stacey D, Légaré F. Evaluation of the effect of a patient decision aid about vasectomy on the decision-making process: a randomized trial. Contraception. 2010;82(6):556–62.PubMedCrossRef
74.
Garrison LP Jr, Mansley EC, Abbott TA 3rd, Bresnahan BW, Hay JW, Smeeding J. Good research practices for measuring drug costs in cost-effectiveness analyses: a societal perspective: the ISPOR drug cost task force report--part II. Value Health. 2010;13(1):8–13.PubMedCrossRef
75.
Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10(8):779–87.PubMedCrossRef
76.
Briggs AH, Claxton K, Sculpher MJ. Decision modelling for health economic evaluation. 1st ed. Oxford: Oxford University Press; 2006.
77.
78.
79.
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321(7262):694–6.PubMedPubMedCentralCrossRef
80.
81.
Trenaman L, Bryan S, Bansback N. The cost-effectiveness of patient decision aids: a systematic review. Healthcare. 2014;2(4):251–7.PubMedCrossRef
82.
Keogh-Brown MR, Bachmann MO, Shepstone L, Hewitt C, Howe A, Ramsay CR, et al. Contamination in trials of educational interventions. Health Technol Assess. 2007;11(43):1–130.
83.
Puffer S, Torgerson D, Watson J. Evidence for risk of bias in cluster randomised trials: review of recent trials published in three general medical journals. BMJ. 2003;327(7418):785–9.PubMedPubMedCentralCrossRef
Metadata
Title
The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: study protocol of a multicenter randomized controlled trial
Authors
Jacqueline A. ter Stege
Leonie A. E. Woerdeman
Daniela E. E. Hahn
Martine A. van Huizum
Frederieke H. van Duijnhoven
Jacobien M. Kieffer
Valesca P. Retèl
Kerry A. Sherman
Arjen J. Witkamp
Hester S. A. Oldenburg
Eveline M. A. Bleiker
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2019
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-019-0873-1

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